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    Clinical Trial Results:
    A placebo-controlled double blind, randomised feasibility trial of Desmopressin (DDAVP) in critical illness prior to procedures.

    Summary
    EudraCT number
    		 2016-001126-33
    Trial protocol
    		 GB  
    Global end of trial date
    22 Oct 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Oct 2021
    First version publication date
    13 Oct 2021
    Other versions
    Summary report(s)
    		 Addendum - Study Continuous Characteristics

    Trial information

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    Trial identification
    Sponsor protocol code
    15/87
    Additional study identifiers
    ISRCTN number
    		 ISRCTN12845429
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    NHS Blood and Transplant
    Sponsor organisation address
    Oak House, Reeds Crescent, Watford, United Kingdom, WD24 4QN
    Public contact
    Miss Emma Laing, NHS Blood and Transplant Clinical Trials Unit, +44 01223588091, emma.laing@nhsbt.nhs.uk
    Scientific contact
    Miss Emma Laing, NHS Blood and Transplant Clinical Trials Unit, +44 01223588091, emma.laing@nhsbt.nhs.uk
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    09 Jun 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Jun 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a feasibility trial, to evaluate whether it is feasible to administer desmopressin (or placebo) prior to an interventional procedure, in order to reduce the patient's risk of bleeding. The primary outcome will measure the proportion of eligible patients who are randomised into trial and receive the IMP.
    Protection of trial subjects
    The majority of participants screened and enrolled into the study were incapacitated at the point of study entry due to the severity of their condition. The protocol therefore allowed for patients to be consented into the study via a Personal or Professional Legal Representative, or via the waiver of consent (if the procedure was an emergency). If the emergency waiver was used, full informed consent was then sought later. Patients were also approached for consent if/when capacity was regained. The process for consent was approved by an approved Research Ethics Committee in the UK.
    Background therapy
    		 Approximately one third of patients in intensive care have a low platelet count and the majority undergo at least one invasive procedure during their time in intensive care, putting them at an increased risk of bleeding. This trial assessed the feasibility of administering desmopressin to thrombocytopenic patients in Intensive Care prior to a procedure or radiological intervention, for prophylaxis against bleeding. There were no restrictions on concomitant care for participants in this trial.
    Evidence for comparator
    		 Not applicable - this was a trial comparing desmopressin (intervention) to placebo (saline).
    Actual start date of recruitment
    01 Feb 2017
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 214
    Worldwide total number of subjects
    214
    EEA total number of subjects
    0
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    199
    From 65 to 84 years
    14
    85 years and over
    1

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment start date: 13/03/2017 Recruitment end date: 06/06/2019 UK only (three participating hospitals).

    Pre-assignment
    Screening details
    		 A total of 384 screenings were undertaken across three centres at Oxford University Hospitals (Oxford), Royal Berkshire Hospital (Reading) and University Hospital of Wales (Cardiff). These screenings resulted in 213 patients fulfilling the study’s eligibility criteria.

    Pre-assignment period milestones
    Number of subjects started
    		 214
    Number of subjects completed
    		 43 [1]

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Not approached: 5
    Reason: Number of subjects
    		 Declined: 15
    Reason: Number of subjects
    		 Patient missed: 134
    Reason: Number of subjects
    		 Clinical decision: 8
    Reason: Number of subjects
    		 Other: 9
    Notes
    [1] - The number of subjects reported to be in the pre-assignment period is not consistent with the number starting period 1. It is expected that the number completing the pre-assignment period are also present in the arms in period 1.
    Justification: In total, 214 participants were screened resulting in 43 participants that were randomised (171 not randomised).
    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor
    Blinding implementation details
    In this trial the participants, the PI, Research Nurse(s), other local Investigators, Trial Statistician and all members of the Clinical Trials Unit were blinded to the treatment allocation. An Independent Statistician produced the allocation sequence. There were members of the site team who were unblinded - these staff performed randomisation and preparation of the IMP infusion, but were not involved in follow-up assessments after that point.

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Desmopressin
    Arm description
    		 A single intravenous infusion of desmopressin (0.3μg/kg in 50mL 0.9% sodium chloride), slowly infused over 20 minutes.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desmopressin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single infusion of 0.3μg/kg desmopressin acetate in 50mL 0.9% saline given over 20 minutes.

    Arm title
    		 Placebo
    Arm description
    		 A placebo control of a single intravenous infusion of 50mL 0.9% sodium chloride, also infused intravenously over 20 minutes.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single intravenous infusion of 50mL 0.9% sodium chloride, infused over 20 minutes.

    Arm title
    		 Eligible not randomised
    Arm description
    		 The number of patients who were found to be eligible for the trial but were not consented/randomised for the reasons shown below: • Not approached (n=5) • Declined to participate (n=15) • Clinical decision (n=8) • Patient missed (n=134) • Other (n=9 )
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 Eligible and randomised
    Arm description
    		 The number of patients who were found to be eligible for the trial and were consented/randomised into one of the two arms (desmopressin or placebo).
    Arm type
    		 Experimental

    Investigational medicinal product name
    Desmopressin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single infusion of 0.3μg/kg desmopressin acetate in 50mL 0.9% saline given over 20 minutes.

    Investigational medicinal product name
    Sodium Chloride
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    A single intravenous infusion of 50mL 0.9% sodium chloride, infused over 20 minutes.

    Number of subjects in period 1
    		Desmopressin Placebo Eligible not randomised Eligible and randomised
    Started
    21
    22
    171
    43
    Completed
    19
    21
    171
    40
    Not completed
    2
    1
    0
    3
         Physician decision
    1
    -
    -
    -
         Consent withdrawn by subject
    1
    -
    -
    2
         Protocol deviation
    -
    1
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Desmopressin
    Reporting group description
    		 A single intravenous infusion of desmopressin (0.3μg/kg in 50mL 0.9% sodium chloride), slowly infused over 20 minutes.

    Reporting group title
    Placebo
    Reporting group description
    		 A placebo control of a single intravenous infusion of 50mL 0.9% sodium chloride, also infused intravenously over 20 minutes.

    Reporting group title
    Eligible not randomised
    Reporting group description
    		 The number of patients who were found to be eligible for the trial but were not consented/randomised for the reasons shown below: • Not approached (n=5) • Declined to participate (n=15) • Clinical decision (n=8) • Patient missed (n=134) • Other (n=9 )

    Reporting group title
    Eligible and randomised
    Reporting group description
    		 The number of patients who were found to be eligible for the trial and were consented/randomised into one of the two arms (desmopressin or placebo).

    Reporting group values
    		 Desmopressin Placebo Eligible not randomised Eligible and randomised Total
    Number of subjects
    		 21 22 171 43 214
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 13 14 0 27 27
        From 65-84 years
    		 7 7 0 14 14
        85 years and over
    		 0 1 0 1 1
        Not recorded
    		 1 0 171 1 172
    Age continuous
    Units: years
        median (full range (min-max))
    		 58 (22 to 78) 60 (28 to 87) 59 (22 to 87) 58 (22 to 87) -
    Gender categorical
    Units: Subjects
        Female
    		 9 9 0 18 18
        Male
    		 12 13 0 25 25
        Not recorded
    		 0 0 171 0 171
    ICU Admission Reason (National Audit and Research Centre Codes – ICNARC)
    Units: Subjects
        Bowel obstruction
    		 1 1 0 2 2
        Haemorrhage
    		 2 0 0 2 2
        Infection
    		 11 15 0 26 26
        Liver cirrhosis
    		 1 2 0 3 3
        Malignancy
    		 3 0 0 3 3
        Trauma
    		 0 2 0 2 2
        Other
    		 1 2 0 3 3
        Not recorded
    		 2 0 171 2 173
    Procedure Type
    Units: Subjects
        Arterial line insertion
    		 2 1 0 3 3
        Central venous catheter insertion
    		 3 6 0 9 9
        Vascath insertion
    		 2 2 0 4 4
        Drain insertion
    		 1 1 0 2 2
        Lumbar puncture
    		 0 1 0 1 1
        Pulmonary artery catheter insertion
    		 1 0 0 1 1
        Arterial Line Removal
    		 3 2 0 5 5
        Central venous catheter removal
    		 4 5 0 9 9
        Vascath removal
    		 3 3 0 6 6
        Arterial line & Central venous catheter insertion
    		 1 0 0 1 1
        Drain removal
    		 0 1 0 1 1
        Not recorded
    		 1 0 171 1 172
    Initial consent given by:
    Units: Subjects
        Patient
    		 2 3 0 5 5
        Patient’s representative – personal
    		 5 7 0 12 12
        Patient’s representative – professional
    		 1 0 0 1 1
        Emergency waiver
    		 12 12 0 24 24
        Not recorded
    		 1 0 171 1 172
    ICU admission route:
    Units: Subjects
        Emergency Department
    		 8 6 0 14 14
        Ward
    		 5 7 0 12 12
        Hospital Transfer
    		 0 1 0 1 1
        Theatre
    		 6 7 0 13 13
        Other
    		 1 1 0 2 2
        Not recorded
    		 1 0 171 1 172
    Renal Failure
    Units: Subjects
        None
    		 7 10 0 17 17
        Acute
    		 10 12 0 22 22
        Chronic
    		 2 0 0 2 2
        Not recorded
    		 2 0 171 2 173
    Antiplatelet drugs given within 7 days of randomisation
    Units: Subjects
        Yes
    		 0 1 0 1 1
        No
    		 19 21 0 40 40
        Not recorded
    		 2 0 171 2 173
    Anticoagulant drugs given within 7 days of randomisation
    Units: Subjects
        Yes
    		 6 9 0 15 15
        No
    		 13 13 0 26 26
        Not recorded
    		 2 0 171 2 173
    Procoagulant drugs given within 7 days of randomisation
    Units: Subjects
        Yes
    		 6 6 0 12 12
        No
    		 13 16 0 29 29
        Not recorded
    		 2 0 171 2 173

    End points

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    End points reporting groups
    Reporting group title
    Desmopressin
    Reporting group description
    		 A single intravenous infusion of desmopressin (0.3μg/kg in 50mL 0.9% sodium chloride), slowly infused over 20 minutes.

    Reporting group title
    Placebo
    Reporting group description
    		 A placebo control of a single intravenous infusion of 50mL 0.9% sodium chloride, also infused intravenously over 20 minutes.

    Reporting group title
    Eligible not randomised
    Reporting group description
    		 The number of patients who were found to be eligible for the trial but were not consented/randomised for the reasons shown below: • Not approached (n=5) • Declined to participate (n=15) • Clinical decision (n=8) • Patient missed (n=134) • Other (n=9 )

    Reporting group title
    Eligible and randomised
    Reporting group description
    		 The number of patients who were found to be eligible for the trial and were consented/randomised into one of the two arms (desmopressin or placebo).

    Primary: Proportion of eligible patients who are randomised into trial and receive the IMP.

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    End point title
    		 Proportion of eligible patients who are randomised into trial and receive the IMP. [1]
    End point description
    Primary outcome (feasibility). This is not a comparison between those randomised and not randomised. Therefore the header 'comparison groups' does not apply - we were unable to edit.
    End point type
    Primary
    End point timeframe
    All data between 1 February 2017 and 7 June 2019 was used to calculate the primary outcome.
    Notes
    [1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: This was a feasibility trial and the primary outcome was the 'proportion of eligible patients who are randomised into trial and receive the IMP'.
    End point values
    		 Eligible not randomised Eligible and randomised
    Number of subjects analysed
    171
    40
    Units: Subjects
    171
    40
    Statistical analysis title
    		 Primary outcome
    Statistical analysis description
    Proportion of eligible patients who are randomised into trial and receive the IMP.
    Comparison groups
    Eligible not randomised v Eligible and randomised
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Percentage
    Point estimate
    18.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 13.8
         upper limit
    		 24.7

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    The timeframe for safety reporting in this trial was from the start of trial treatment until 28 days post-trial treatment.
    Adverse event reporting additional description
    All serious adverse events had to be reported in an expedited fashion. All non-serious adverse events did not require reporting.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20.0
    Reporting groups
    Reporting group title
    Desmopressin
    Reporting group description
    		 A single intravenous infusion of desmopressin (0.3μg/kg in 50mL 0.9% sodium chloride), slowly infused over 20 minutes.

    Reporting group title
    Placebo
    Reporting group description
    		 A placebo control of a single intravenous infusion of 50mL 0.9% sodium chloride, also infused intravenously over 20 minutes.

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: Non-serious adverse events were not collected during this trial.
    Serious adverse events
    		 Desmopressin Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    11 / 19 (57.89%)
    13 / 21 (61.90%)
         number of deaths (all causes)
    8
    6
         number of deaths resulting from adverse events
    Vascular disorders
    Axillary vein thrombosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Surgical and medical procedures
    Endotracheal intubation
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Tracheostomy
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Medical device site thrombosis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Multiple organ dysfunction syndrome
         subjects affected / exposed
    4 / 19 (21.05%)
    2 / 21 (9.52%)
         occurrences causally related to treatment / all
    0 / 6
    0 / 6
         deaths causally related to treatment / all
    0 / 4
    0 / 1
    Immune system disorders
    Drug hypersensitivity
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Acute respiratory distress syndrome
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pneumomediastinum
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Pulmonary oedema
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Delirium
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Injury, poisoning and procedural complications
    Endotracheal intubation complication
         subjects affected / exposed
    0 / 19 (0.00%)
    2 / 21 (9.52%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Subarachnoid haemorrhage
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrial fibrillation
         subjects affected / exposed
    2 / 19 (10.53%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Atrioventricular block first degree
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Bradycardia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pulseless electrical activity
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Supraventricular tachycardia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Intracranial mass
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Osmotic demyelination syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Posterior reversible encephalopathy syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood and lymphatic system disorders
    Febrile neutropenia
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Splenic infarction
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal disorders
    Abdominal compartment syndrome
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Intra-abdominal fluid collection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lower gastrointestinal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Rectal haemorrhage
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Alcoholic liver disease
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Hepatic failure
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Renal and urinary disorders
    Acute kidney injury
         subjects affected / exposed
    1 / 19 (5.26%)
    2 / 21 (9.52%)
         occurrences causally related to treatment / all
    0 / 3
    0 / 3
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Infections and infestations
    Candida infection
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Epididymitis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Herpes simplex
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Lung abscess
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pneumonia
         subjects affected / exposed
    1 / 19 (5.26%)
    3 / 21 (14.29%)
         occurrences causally related to treatment / all
    0 / 4
    0 / 4
         deaths causally related to treatment / all
    0 / 0
    0 / 1
    Pneumonia fungal
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 1
    0 / 0
    Sepsis
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Septic shock
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 21 (4.76%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 2
         deaths causally related to treatment / all
    0 / 1
    0 / 1
    Metabolism and nutrition disorders
    Hypernatraemia
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 21 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Desmopressin Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 21 (0.00%)

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    11 Oct 2017
    CHANGES TO INCLUSION / EXCLUSION CRITERIA: - addition of inclusion of patients who are in the process of being admitted to ICU, in addition to those already on ICU. - re-defined exclusion of 'active bleeding' to 'haemorrhagic shock'. - re-defined hyponatraemia as serum sodium <=129mmol/l. CLARIFICATION ON DOSING IMP FOR PATIENTS WITH BMI > 30kg/m2 OR FLUID OVERLOAD. ADDITION OF TWO NEW SITES.
    08 Feb 2019
    ADDITION OF TTP (Thrombotic Thrombocytopenic Purpura) AS AN EXCLUSION CRITERION CORRECTION OF ERROR IN SAFETY REPORTING SECTION DATA SHARING POLICY (ADDED DETAILS)
    12 Jul 2019
    ADDITION OF SECONDARY OUTCOME MEASURE RELATING TO RESEARCH ASSAY TESTS

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The study continuous characteristics (e.g. platelet count, APACHEII, GCS score) could not be submitted as part of this dataset for technical reasons. The results for these characteristics (by desmopressin and placebo groups) are available on request.
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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