Condition category
Circulatory System
Date applied
06/11/2017
Date assigned
19/12/2017
Last edited
19/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Administration of fluids directly into a vein is commonly used to treat low blood pressure in critically ill patients. The aim of such so-called fluid resuscitation is to increase the circulating blood volume to improve the blood flow to body organs. Prolonged fluid resuscitation may, however, lead to fluid accumulation in the tissues, which contributes to organ damage and even increased mortality. Albumin is a natural part of human blood with a high ability to bind water. In the United Kingdom, two different albumin-containing solutions are widely and routinely used for fluid resuscitation; a 5% solution (containing 50 mg albumin per ml) and a concentrated 20% solution (containing 200 mg albumin per ml). Theoretically, the concentrated 20% albumin solution can accomplish the same volume expansion effect as the 5% solution using only one fifth of the administered volume. A reduced volume of fluid administered may ultimately attenuate the severity of organ damage, expedite recovery from the critical illness and reduce mortality. The aim of this study is to test whether fluid resuscitation with 20% albumin solution reduces the accumulation of fluid and organ damage in critically ill patients as compared to fluid resuscitation with the 5% albumin solution.

Who can participate?
Adults aged 18 and older who are in the critical care.

What does the study involve?
Participants in intensive care who are in need of intravenous fluid resuscitation are randomly allocated to receiving either 20% or 5% human albumin solution as their resuscitation fluid for 48 hours from the time of randomisation. The volume of fluid and its rate of delivery will be at the discretion of the treating physician. All other care and interventions are provided according to local policy and the discretion of the treating physician. Participants are followed throughout their hospital stay.

What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. There are no specific risks to taking part aside from patients providing additional blood samples (approx 12ml per fluid challenge delivered) and those incumbent with human albumin solution. Albumin solutions have been used for resuscitation since the 1940s. An investigation of the safety of albumin solutions showed that between 1998 and 2000, approximately 107 units of such albumin solutions were administered worldwide. Adverse effects that were directly associated with albumin were an extremely rare event during this observation period. There are, however, more recent reports that the use of (20%) albumin is associated with increased mortality for patients with traumatic brain injury. Accordingly, patients with traumatic brain injury will be excluded from the study. Although albumin is prepared from pooled plasma, albumin preparations currently available are considered to be non-allergenic due to the manufacturing process.

Where is the study run from?
1. Manchester Royal Infirmary (UK)
2. Austin Hospital (Australia)
3. Flinders Medical Centre (Australia)

When is the study starting and how long is it expected to run for?
September 2015 to December 2017

Who is funding the study?
CSL Behring UK Limited (UK)

Who is the main contact?
Dr Jonathan Bannard-Smith
j.bannardsmith@cmft.nhs.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Jonathan Bannard-Smith

ORCID ID

Contact details

Department of Critical Care
2nd Floor Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 1612 764712
j.bannardsmith@cmft.nhs.uk

Additional identifiers

EudraCT number

2016-001940-20

ClinicalTrials.gov number

Protocol/serial number

32455

Study information

Scientific title

A pilot, randomised, unlinded, feasibility, safety and biochemical and physiological efficacy study of 20% versus 5% human albumin solution for fluid bolus therapy in critically ill adults

Acronym

SWIPE

Study hypothesis

The aim of this study is to test whether fluid resuscitation with 20% albumin solution reduces the accumulation of fluid and organ damage in critically ill patients as compared to fluid resuscitation with the 5% albumin solution.

Ethics approval

Yorkshire & The Humber - Sheffield Research Ethics Committee, 11/10/2016, ref: 16/YH/0349

Study design

Randomised; Both; Design type: Treatment, Drug, Not Specified

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Specialty: Critical care, Primary sub-specialty: Critical Care; UKCRC code/ Disease: Generic Health Relevance/ No specific disease

Intervention

In this prospective physiological feasibility study adult patients in intensive care who are in need of intravenous fluid resuscitation are randomly allocated to receiving either 20% or 5% human albumin solution as their resuscitation fluid for 48 hours from the time of randomisation. The volume of fluid and its rate of delivery will be at the discretion of the treating physician. All other care and interventions will be provided according to local policy and the discretion of the treating physician.

Participants are followed through their stay in hospital measuring how much fluid they receive and other data concerning vital organ function including the results of additional blood tests and their eventual outcomes.

Intervention type

Other

Phase

Phase IV

Drug names

Primary outcome measures

Volume of resuscitation fluid delivered is measured using standard nursing bedside assessment and documentation of all fluid administered at 48 hours.

Secondary outcome measures

1. The cumulative fluid balance is measured using standard nursing bedside assessment and documentation after 48 hours in ICU 2. The amount of vasoactive medication given over the first 4 hours after a fluid bolus and over the first 48 hours in ICU is measured using standard nursing bedside assessment and documentation.
3. The total amount of fluids given over the first 4 hours after a fluid bolus, daily and over the first 48 hours in ICU is measured using standard nursing bedside assessment and documentation.
4. The relative change in haemodynamic variables and blood gas results over the first 4 hours after a fluid bolus is measured using standard data documented on the patients ICU chart just prior to randomisation and then at 1, 2 and 4 hours following.
5. The relative change between baseline and peak creatinine in the first 48 hours after randomization is measured using our institution’s standard renal blood profiles of samples taken just prior to randomisation, and also at 24 and 48 hours later.

Overall trial start date

01/09/2015

Overall trial end date

31/12/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Admitted to the Department of Intensive Care, Austin Hospital for less than 24 hours or to the Intensive and Critical Care Department of the Flinders Medical Centre for less than 24 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 400; UK Sample Size: 20

Participant 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)

Recruitment start date

01/01/2017

Recruitment end date

09/03/2017

Locations

Countries of recruitment

Australia, United Kingdom

Trial participating centre

Manchester Royal Infirmary
Central Manchester University Hospitals Oxford Road
Manchester
M13 9WL
United Kingdom

Trial participating centre

Austin Hospital
145 Studley Road
Heidelberg
VIC 3084
Australia

Trial participating centre

Flinders Medical Centre
Flinders Drive Bedford Park
Adelaide
SA 5042
Australia

Sponsor information

Organisation

Central Manchester University Hoapitals NHS Foundation Trust

Sponsor details

Trust Headquarters
Cobbett House
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

CSL Behring UK Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Austin Medical Research Foundation

Alternative name(s)

AMRF

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

Australia

Results and Publications

Publication and dissemination plan

The study will be published in the name of the of the study investigators. The chief investigator will be listed as the first author and other members of the management committee will be listed alphabetically. Funding bodies will be acknowledged in the publication.
Following completion of the study and data analysis the study results will be published in a peer-reviewed critical care journal and presented at local and national intensive care conferences. In addition, we will provide a summary of the study and its findings to the staff of the two study sites.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available due to
1. The physiological findings will be of a pilot investigation in nature.
2. The implications of the findings are uncertain beyond those of the main study and only aim to assist clinicians' in perhaps understating more clearly possible impact behind differences in fluid choice that might become apparent from the findings of the study.

Intention to publish date

01/06/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

19/12/2017: The registration of this study was requested through the NIHR Portfolio. The trialist confirmed the recruitment start and end dates. Uploaded protocol Version 2.2 18 May 2017 (not peer-reviewed).