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    Clinical Trial Results:
    The effect of hypertonic saline on blood electrolytes, acid-base balance and hormones that regulate blood pressure

    Summary
    EudraCT number
    		 2013-004466-34
    Trial protocol
    		 FI  
    Global end of trial date
    23 May 2017

    Results information
    Results version number
    		 v1(current)
    This version publication date
    24 Jan 2025
    First version publication date
    24 Jan 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    005,1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Helsinki University Central Hospital
    Sponsor organisation address
    Haartmaninkatu 4 C, Helsinki, Finland, 00290
    Public contact
    Department of Ophthalmology, Helsinki University Central Hospital, +358 947173161, pia.inborr@outlook.com
    Scientific contact
    Department of Ophthalmology, Helsinki University Central Hospital, +358 947173161, pia.inborr@outlook.com
    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
    Interim
    Date of interim/final analysis
    23 May 2017
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 May 2017
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To study the safety of intravenous hypertonic saline in reducing intraocular pressure
    Protection of trial subjects
    We required the patients to be fluent in Finnish or Swedish. We excluded patients diagnosed with heart and kidney failure, dementia, or another condition that markedly decreased their physical performance. We measured blood pressure and heart rate automatically with an anaesthesia monitor. We took measurements before the bolus (baseline), 10, 20, 60 and 120 minutes after the bolus. We asked the patients to grade the pain at the infusion site on a scale from 0 to 10; zero for no pain, and 10 for the most intense (intolerable) pain. Any other side effect was additionally recorded.
    Background therapy
    		 We cannulated an antecubital vein in either the right or left arm. We rinsed the cannula with 3 ml physiologic saline to confirm its intravenous position. The IVTHS dose corresponds to a 20 ml injection for an 80 kg patient. We infused the bolus at 1 ml/s, and then rinsed the cannula and vein with physiologic saline using 5 ml after the bolus.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    25 Feb 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Finland: 1
    Worldwide total number of subjects
    1
    EEA total number of subjects
    1
    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)
    1
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Eligible to our study were patients who were 25–80 years old. We required the patients to be fluent in Finnish or Swedish. We excluded patients diagnosed with heart and kidney failure, dementia, or another condition that markedly decreased their physical performance.

    Pre-assignment
    Screening details
    		 We screened three patients for the study. One patient was excluded because we could not get any blood from the cannulated vein. One patient was excluded because of high blood pressure and severe obesity.

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Overall study
    Arm description
    		 All patients who received hypertonic NaCl intravenously.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Natriumklorid Braun 234 mg/ml
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Concentrate and solvent for solution for injection
    Routes of administration
    Intravenous use
    Dosage and administration details
    We cannulated an antecubital vein in either the right or left arm. We rinsed the cannula with 3 ml physiologic saline to confirm its intravenous position. The dosage of IVHTS was 1 mmol/kg sodium chloride in all patients. We infused the bolus at 1 ml/s, and then rinsed the cannula and vein with physiologic saline using 5 ml after the bolus. We took blood samples from the same cannula.

    Number of subjects in period 1
    		Overall study
    Started
    1
    10 minutes
    1
    20 minutes
    1
    60 minutes
    1
    120 minutes
    1
    Completed
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 All patients

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 1 1
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Adults
    		 1 1
    Gender categorical
    Eligible to our study were men and women who were 25–80 years old.
    Units: Subjects
        Female
    		 1 1
        Male
    		 0 0
    Subject analysis sets

    Subject analysis set title
    Laboratory values
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The study ended prematurely. We only studied one patient. We had problems with the blood sample collection from the patients.

    Subject analysis sets values
    		 Laboratory values
    Number of subjects
    1
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    0
        From 65-84 years
    0
        85 years and over
    0
        Adults
    1
    Age continuous
    Units:
        
    ( )
    Gender categorical
    Eligible to our study were men and women who were 25–80 years old.
    Units: Subjects
        Female
    1
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Overall study
    Reporting group description
    		 All patients who received hypertonic NaCl intravenously.

    Subject analysis set title
    Laboratory values
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The study ended prematurely. We only studied one patient. We had problems with the blood sample collection from the patients.

    Primary: Laboratory values 120 minutes after the bolus

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    End point title
    		 Laboratory values 120 minutes after the bolus [1]
    End point description
    We took blood samples from the patiens before the NaCl-bolus (baseline) and 10, 20, 60 ja 120 minutes after the bolus. We studied the following values: Na, K, Cl, Ca, albumin, phosphate, renin, aldosterone, serum osmolality, copeptin and blood gas analysis from the venous blood (pH, PCO2, base excess).
    End point type
    Primary
    End point timeframe
    Laboratory values 120 minutes after bolus.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: No results to be analysed.
    End point values
    		 Laboratory values
    Number of subjects analysed
    1
    Units: 1
    1
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    120 minutes after the hypertonic saline bolus.
    Adverse event reporting additional description
    We asked the patients to grade the pain at the infusion site on a scale from 0 to 10; zero for no pain, and 10 for the most intense (intolerable) pain. Any other side effect was additionally recorded.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 VAS
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Whole study
    Reporting group description
    		 All patients.

    Serious adverse events
    		 Whole study
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 1 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Whole study
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 1 (100.00%)
    Vascular disorders
    Headache
    Additional description: Occipital pain. VAS 3.
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain in the arm
    Additional description: Pain in the infusion arm for 2.5 minutes time. VAS 3.
         subjects affected / exposed
    1 / 1 (100.00%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    23 May 2017
    We had problems taking blood samples from the cannula in the vein. We could only get the baseline samples and 10 minutes samples (one patient).
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    We managed to study only one patient partially.
    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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