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Trial registered on ANZCTR


Registration number
ACTRN12615000349549
Ethics application status
Approved
Date submitted
7/04/2015
Date registered
17/04/2015
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Date results information initially provided
13/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluation of intravenous fluid resuscitation with either 4% albumin or 20% albumin solution for patients admitted to the intensive care unit
Scientific title
A Pilot, Randomised, Unblinded, Feasibility, Safety and Biochemical and Physiological Efficacy Study of 20% vs 4% Human Albumin Solution for Fluid Bolus Therapy in Critically Ill Adults
Secondary ID [1] 286079 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SWIPE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Low blood volume states 294078 0
Critical illness 294739 0
Condition category
Condition code
Cardiovascular 294380 294380 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following blinded allocation, eligible enrolled patients admitted to the intensive care unit will:
1. During the first 48 hrs in intensive care patient to receive intravenous 4% albumin bolus in volumes prescribed as required by their treating intensive care doctor.
2. In the intensive care unit - other intravenous fluids/blood products given as required by their treating intensive care doctor.
3. If patient needs to return to theatre, IV fluids as per treating anaesthetic team.
4. After 48 hrs – bolus fluid therapy as per intensive care unit medical team.






Intervention code [1] 291071 0
Treatment: Drugs
Comparator / control treatment
Following blinded allocation, eligible enrolled patients admitted to the intensive care unit will:
1. During the first 48 hrs in intensive care patient to receive intravenous 20% albumin bolus as required by their treating intensive care doctor.
2. In the intensive care unit - other intravenous fluids/blood products given as required by their treating intensive care doctors.
3. If patient needs to return to theatre, intravenous fluids as per treating anaesthetic team.
4. After 48 hrs – bolus fluid therapy as per the intensive care medical team.

Control group
Dose comparison

Outcomes
Primary outcome [1] 294172 0
Administered volume of fluid for resuscitation as per the patient's daily fluid balance chart.
Timepoint [1] 294172 0
During the first 48 hours following randomisation
Secondary outcome [1] 312669 0
Cumulative fluid balance as per the patient's daily fluid balance chart.
Timepoint [1] 312669 0
Over the first 48 hours following randomisation
Secondary outcome [2] 312670 0
Volume of intravenous vasoactive medication as per the patient's daily fluid balance chart.
Timepoint [2] 312670 0
Administered over the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.
Secondary outcome [3] 312671 0
Cumulative volume of intravenous vasoactive medication as per the patient's daily fluid balance chart.
Timepoint [3] 312671 0
Administered over the first forty-eight hours after the initial fluid resuscitation bolus with albumin following enrolment.
Secondary outcome [4] 312672 0
Total volume of intravenous fluids received by the patient as per the patient's daily fluid balance chart.
Timepoint [4] 312672 0
Administered in the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.
Secondary outcome [5] 312673 0
Total volume of intravenous fluids as per the patient's daily fluid balance chart.
Timepoint [5] 312673 0
Administered in the first forty-eight hours after the initial fluid resuscitation bolus with albumin following enrolment.
Secondary outcome [6] 312674 0
Relative change in blood pressure variables data
Timepoint [6] 312674 0
Occuring over the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.
Secondary outcome [7] 312675 0
Relative change in arterial blood gas data
Timepoint [7] 312675 0
Occuring over the first forty-eight hours after the initial fluid resuscitation bolus with albumin following enrolment.
Secondary outcome [8] 312676 0
Relative change between baseline and peak serum creatinine
Timepoint [8] 312676 0
Over the first four hours after the initial fluid resuscitation bolus with albumin following enrolment.

Eligibility
Key inclusion criteria
1. Admitted to the Department of Intensive Care, Austin Hospital for less than 48 hours or to the Intensive and Critical Care Department of the Flinders Medical Centre for less than 48 hours.
2. Age 18 years or greater
3. Need for fluid bolus as determined by the treating clinician
4. Presence of one or more of the following physiological states: systolic BP <90 mmHg, or MAP <65 mmHg, or increasing need for vasopressor drug infusion or pulse pressure variation >12 % or stroke volume variation >12%, or Cardiac index <2.2 L/min/m2 or heart rate >100 or urinary output <20 ml/hr or either rising lactate levels or lactate levels >2 mmol/L or capillary refill time >3 seconds or central venous pressure <8 mmHg.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Confirmed or suspected pregnancy
2. Patients with traumatic brain injury
3. Active bleeding
4. Haemoglobin level <70 g/L
5. People who refuse blood products
6. Patients in whom death is considered imminent (within 24 hours)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
1. Each envelope will contain a study arm allocation as well as a copy of a simplified version of the study protocol.
2. Every patient who participates in any study related procedure will be assigned a unique patient number.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
1. Computer generated sets of random allocations will be produced by the Research Co-ordinator in advance of the study.
2. Randomization will be by means of sealed envelopes with permuted blocks of variable size.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 3378 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 3379 0
Flinders Medical Centre - Bedford Park

Funding & Sponsors
Funding source category [1] 290664 0
Hospital
Name [1] 290664 0
Austin Hospital
Address [1] 290664 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 290664 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Austin Health
145 Studley Road
Heidelberg VIC 3084
Country
Australia
Secondary sponsor category [1] 289357 0
Individual
Name [1] 289357 0
Professor Rinaldo Bellomo
Address [1] 289357 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country [1] 289357 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292293 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 292293 0
Austin Health
145 Studley Road
Heidelberg VIC 3084
Ethics committee country [1] 292293 0
Australia
Date submitted for ethics approval [1] 292293 0
25/11/2014
Approval date [1] 292293 0
30/03/2015
Ethics approval number [1] 292293 0
HREC/14/Austin/589

Summary
Brief summary
Administration fluids directly into a vein is commonly used to treat low blood pressure in critically ill patients, termed fluid resuscitation. The aim of fluid resuscitation is to restore and maintain organ function. Two commonly administered intravenous fluids are 20% albumin and 4% albumin. Intensive care doctors do not known if either of these two fluids should be used in preference to the other for fluid resucitation.

In response, the aim of this study is to establish the feasibility, safety, biochemical and physiologicy efficacy of intravenous 20% albumin solution compared with intravenous 4% albumin soluation for fluid bolus therapy in critically ill patients.

For a period of 48 hours from enrolment, patients that are enrolled in this study will receive either of the study fluids when their treating intensive care doctors deems it necessary. This study will enrol 400 patients for two intensive care units of hospitals located in Melbourne and Adelailde, Australia.

If our findings support one intravnous fluid over the other then we would aim to conduct larger studies to assess its benefits in terms of patient-centred outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54522 0
Prof Rinaldo Bellomo
Address 54522 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54522 0
Australia
Phone 54522 0
+61 3 9496 5992
Fax 54522 0
+61 3 9496 3932
Email 54522 0
rinaldo.bellomo@austin.org.au
Contact person for public queries
Name 54523 0
A/Prof Glenn Eastwood
Address 54523 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54523 0
Australia
Phone 54523 0
+61 3 9496 4835
Fax 54523 0
+61 3 9496 3932
Email 54523 0
glenn.eastwood@austin.org.au
Contact person for scientific queries
Name 54524 0
Prof Rinaldo Bellomo
Address 54524 0
Department of Intensive Care
Austin Hospital
145 Studley Road
Heidelberg VIC 3084
Country 54524 0
Australia
Phone 54524 0
+61 3 9496 5992
Fax 54524 0
+61 3 9496 3932
Email 54524 0
rinaldo.bellomo@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Administration of intravenous fluid for the rapid restoration of blood pressure with 20% albumin fluid solution decreased total resuscitation fluid requirements, minimized positive early fluid balance and was not associated with any evidence of harm compared with 4-5% albumin fluid solution. These findings support the safety of further exploration of resuscitation with 20% albumin solution in larger randomised trials.