Randomised comparison of fluid resuscitation with human albumin solution or normal saline among critically ill patients

Not Applicable

Completed

• Conditions: Critically ill patients requiring intravenous fluid resuscitation; Signs and Symptoms; Intravenous fluid resuscitation

• Registration Number: ISRCTN76588266
• Lead Sponsor: The George Institute for International Health (Australia)

Brief Summary

2006 Results article in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17040925 2007 Results article in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17761591

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-09-19
• Study Completion: 2004-12-31
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 7000

Inclusion Criteria

Patients are eligible for inclusion in the study if ALL the following requirements are met:
1. Fluid resuscitation is required for intravascular fluid depletion that is in addition to intravenous fluid that is required for nutrition or to replace ongoing insensible losses, urinary losses, ongoing losses from other sites (e.g., fistula losses from the gastrointestinal tract, urinary losses from diabetes insipidus, cerebral salt wasting syndrome or the polyuric phase of acute renal failure) or to restore normonatraemia
2. The ICU clinician considers that both 4% human albumin solution and 0.9% sodium chloride are equally appropriate for the patient and that no specific indication or contraindication for either exists
3. The requirement for fluid resuscitation must be supported by AT LEAST ONE of the following clinical signs:
a. Heart rate greater than 90 beats/min
b. Systolic Blood Pressure (SBP) less than 100 mmHg or Mean Arterial Pressure (MAP) less than 75 mmHg or a 40 mmHg decrease in SBP or MAP from the baseline recording
c. Central venous pressure less than 10 mmHg
d. Pulmonary artery wedge pressure less than 12 mmHg
e. Respiratory variation in systolic or mean arterial blood pressure of greater than 5 mmHg
f. Capillary refill time greater than one second
g. Urine output less than 0.5 ml/kg for one hour

Exclusion Criteria

Patients are excluded from the study if one or more of the following are present:
1. A known previous adverse reaction to human albumin solution
2. Any known religious objection to the administration of human blood products (for example if patient is a Jehovah?s Witness)
3. A requirement for the patient to receive plasmapheresis during this ICU admission
4. An admission to the ICU following cardiac surgery
5. An admission to the ICU for the treatment of body burn
6. An admission to the ICU following liver transplantation surgery
7. Age less than 18 years
8. Brain death or brain death that is likely to be diagnosed within in the next 24 hours of fluid resuscitation being required
9. If the patient is moribund and expected to die within the next 24 hours - defined as having a treatment limitation order in place that exceeds a ?not for resuscitation? order and that indicates the treating clinicians are not committed to full supportive care
10. If the patient has previously been enrolled and has completed follow up in the SAFE study
11. If the patient has previously received fluid resuscitation that was prescribed within the study ICU and during this current ICU admission
12. If the patient has been transferred to the study ICU from a non-study ICU and received a fluid bolus or fluid resuscitation for the treatment of volume depletion in that non-study ICU

Study & Design

• Study Type: Interventional
• Study Design: Not specified