Clinical Trial Results:
A Pilot, Randomised, Unblinded, Feasibility, Safety, Biochemical and Physiological Efficacy Study of 20% vs 5% Human Albumin Solution for Fluid Bolus Therapy in Critically Ill Adults
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Summary
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EudraCT number |
2016-001940-20 |
Trial protocol |
GB |
Global end of trial date |
30 Jun 2017
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Results information
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Results version number |
v1(current) |
This version publication date |
14 May 2020
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First version publication date |
14 May 2020
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Other versions |
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Summary report(s) |
Published trial manuscript SWIPE Trial supplementary appendix |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
R04336
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Additional study identifiers
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ISRCTN number |
ISRCTN15839026 | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Australian & New Zealand Clinical Trials Registry: ACTRN12615000349549 | ||
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Sponsors
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Sponsor organisation name |
Manchester University NHS Foundation Trust
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Sponsor organisation address |
Oxford Road, Manchester, United Kingdom, M13 9WL
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Public contact |
Lynne Webster, Manchester University NHS Foundation Trust, +44 01612764125, lynne.webster@mft.nhs.uk
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Scientific contact |
Lynne Webster, Manchester University NHS Foundation Trust, +44 01612764125, lynne.webster@mft.nhs.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2017
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
30 Jun 2017
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Global end of trial reached? |
Yes
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Global end of trial date |
30 Jun 2017
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Our principle aim is to compare the effects of 5% versus 20% albumin solution when given as fluid resuscitation in critically ill adults. As this is a pilot study, the main objective is to test whether the study processes and procedures are both feasible and safe.
The sorts of effects we will compare include routine observations such as heart rate, blood pressure and the amount of urine a patient produces every hour. We will also compare the biochemical levels of sodium and chloride in patient's blood. The most important comparison we will make is the total amount of fluid (in ml) that patients receive during the study period.
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Protection of trial subjects |
There is the possibility that patients may not have the capacity to consent so the study would allow their personal or professional legal representative to provide valid consent on their behalf. This process is in keeping with standard and established approach to consent in critically ill incapacitated adults. Retrospective consent would then be sought once the patient was able.
Additional blood samples will be taken in addition to standard care at 1, 2 and 4 hours post infusion when the patient will still be present in Intensive Care Unit.
The study was run in the UK and also in Australia and care was taken when sending UK data over to Australia, that no identifying information was included. It was sent via an encrypted database.
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Background therapy |
There are no mandated background therapy's however nor does the protocol restrict any other treatment a patient may be given such as oxygen therapy, antibiotics, radiological interventions, blood products or surgical intervention. | ||
Evidence for comparator |
Both 5% and 20% albumin solutions are legally licenced for use as fluid resuscitation. Both solutions are in widespread use for this purpose around the world but have never been compared before. It is hypothesized that those patients receiving 20% solution, which is more concentrated, will receive less fluid, sodium and chloride and thus potentially be at a reduced risk of organ failure and death. | ||
Actual start date of recruitment |
01 Apr 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 20
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Country: Number of subjects enrolled |
Australia: 307
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Worldwide total number of subjects |
327
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EEA total number of subjects |
20
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
164
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From 65 to 84 years |
148
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85 years and over |
15
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Recruitment
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Recruitment details |
The trial opened to recruitment in Australia on 01/07/2015. The UK site began recruiting on 30/11/2016 and closed on 26/03/2017 at Manchester Royal Infirmary. Patients recruited from Intensive Care Unit who had been there for less than 24 hours. | |||||||||
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Pre-assignment
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Screening details |
Patients admitted to intensive care unit less than 24 hours prior to approach with a requirement to receive fluid bolus as determined by treating clinician | |||||||||
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Pre-assignment period milestones
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Number of subjects started |
327 | |||||||||
Number of subjects completed |
321 | |||||||||
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Pre-assignment subject non-completion reasons
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Reason: Number of subjects |
Consent withdrawn by subject: 6 | |||||||||
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Period 1
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Period 1 title |
Treatment period (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Blinding implementation details |
Blinding in this trial was not possible as the two infusions come in different sized bottles - 20% in 100mL glass bottles and 5% in 500mL bottles.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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5% Albumin group | |||||||||
Arm description |
This group is classed as the control group and will be given 5% Albumin each time the treating physician decides that a fluid bolus needs to be given during the first 48 hours in ICU. | |||||||||
Arm type |
Active comparator | |||||||||
Investigational medicinal product name |
Alburex 5
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Investigational medicinal product code |
B05AA01
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The maximum dose administered will be at the discretion of the treating clinician and within the maximum dosing recommended by the IMPs manufacturer. We expect this to be no more than 4 doses during the 48 hour study period.
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Arm title
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20% Albumin | |||||||||
Arm description |
This group is classed as the treatment group and will be given each time the treating physician decides that a fluid bolus is required during the first 48 hours in the Intensive Care Unit. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Alburex 20
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Investigational medicinal product code |
PL 15036/0032 ATC B05AA01
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Other name |
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Pharmaceutical forms |
Solution for infusion
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Routes of administration |
Intravenous use
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Dosage and administration details |
The maximum dose will be prescribed and administered at the discretion of the treating clinician, within the recommendations provided by the IMPs manufacturer. We do not expect the patient to receive more than 4 doses within the 48 hour study period.
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: Six participants withdrew consent prior to beginning treatment. |
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Baseline characteristics reporting groups
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Reporting group title |
5% Albumin group
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Reporting group description |
This group is classed as the control group and will be given 5% Albumin each time the treating physician decides that a fluid bolus needs to be given during the first 48 hours in ICU. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
20% Albumin
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Reporting group description |
This group is classed as the treatment group and will be given each time the treating physician decides that a fluid bolus is required during the first 48 hours in the Intensive Care Unit. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
5% Albumin group
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Reporting group description |
This group is classed as the control group and will be given 5% Albumin each time the treating physician decides that a fluid bolus needs to be given during the first 48 hours in ICU. | ||
Reporting group title |
20% Albumin
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Reporting group description |
This group is classed as the treatment group and will be given each time the treating physician decides that a fluid bolus is required during the first 48 hours in the Intensive Care Unit. | ||
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End point title |
Volume of resuscitation fluid [1] | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Up to 48 hours after randomisation
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| 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: All data for the primary outcome were visually assessed for normality. In view of its non-parametric distribution we used a Mann-Whitney U test to analyse the difference in the primary outcome measure of median volume of resuscitation fluid. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Cumulative fluid balance | ||||||||||||
End point description |
Total fluid in minus total fluid out, cumulatively up to 48 hours.
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End point type |
Secondary
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End point timeframe |
48 hours after randomisation
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
Up to 90 days following randomisation or hospital discharge (whichever sooner)
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Adverse event reporting additional description |
Hyperalbuminaemia (serum albumin >45 g/L)
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Assessment type |
Systematic | ||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
N/A | ||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
20% Albumin
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Reporting group description |
Hyperalbuminaemia (>45 g/L) as an adverse event | ||||||||||||||||||||||||
Reporting group title |
4% Albumin
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Reporting group description |
Hyperalbuminaemia (>45 g/L) as an adverse event | ||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
