Randomised comparison of fluid resuscitation with human albumin solution or normal saline among critically ill patients
| ISRCTN | ISRCTN76588266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76588266 |
| Secondary identifying numbers | 153711 |
- Submission date
- 19/09/2002
- Registration date
- 19/09/2002
- Last edited
- 08/11/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Robyn Norton
Scientific
Scientific
The George Institute for International Health
Level 24, Maritime Trade Towers
207 Kent Street
Sydney
NSW 2021
Australia
| Phone | + 61 2 9657 0381 |
|---|---|
| rnorton@george.org.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Randomised comparison of fluid resuscitation with human albumin solution or normal saline among critically ill patients |
| Study acronym | SAFE Study (Saline versus Albumin Fluid Evaluation) |
| Study objectives | When 4% albumin is compared to 0.9% sodium chloride (normal saline) for intravascular fluid resuscitation in patients in the Intensive Care Unit (ICU) there is no difference in 28-day all-cause mortality. |
| Ethics approval(s) | Ethics approval at Royal North Shore Hospital (affiliated with the University of Sydney and the Institute for International Health) was issued on 27 November 2000 (protocol ref: 0010-173M). Each participating institution also received ethics approval. |
| Health condition(s) or problem(s) studied | Critically ill patients requiring intravenous fluid resuscitation |
| Intervention | The study treatment will be randomly allocated with stratification within the ICU and across the study population for patients admitted for trauma causes or non-trauma causes. Administration of the study treatments will be double blinded. Each eligible participant will be randomised to receive either 4% human albumin or 0.9% sodium chloride. Co-sponsor for this trial: Australian and New Zealand Intensive Care Society Clinical Trials Group Level 3, 10 Ievers Terrace Carlton, Melbourne 3053 Australia Phone: +61 3 9340 3400 Fax: +61 3 9340 3499 Contact person: Professor Simon Finfer (sfinfer@george.org.au) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Human albumin solution or normal saline |
| Primary outcome measure | Death from all causes at 28 days after randomisation |
| Secondary outcome measures | 1. Survival time during the first 28 days 2. The proportion of patients with one, two, three, four and five new organ failures (defined as documented change in cardiovascular, respiratory, renal, haematologic or hepatic component of the Sepsis-related Organ Failure [SOFA] score from zero, one or two at base-line to three or four during ICU stay) 3. Duration of mechanical ventilation 4. Duration of renal replacement therapy 5. Duration of ICU and hospital stay |
| Overall study start date | 01/01/2003 |
| Completion date | 31/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 7000 |
| Key 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 |
| Key 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 Jehovahs 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 |
| Date of first enrolment | 01/01/2003 |
| Date of final enrolment | 31/12/2004 |
Locations
Countries of recruitment
- Australia
- New Zealand
Study participating centre
The George Institute for International Health
Sydney
NSW 2021
Australia
NSW 2021
Australia
Sponsor information
The George Institute for International Health (Australia)
Research organisation
Research organisation
c/o Professor Simon Finfer
The George Institute for International Health
Level 24, Maritime Trade Towers
207 Kent Street
Sydney
NSW 2021
Australia
| Website | http://www.thegeorgeinstitute.org |
|---|---|
"ROR" |
https://ror.org/023331s46 |
Funders
Funder type
Hospital/treatment centre
Funding has been from several organisations (listed in alphabetical order):
No information available
Auckland Hospital (New Zealand)
No information available
Commonwealth Department of Health and Aged Care (Australia)
No information available
CSL Limited, Melbourne (Australia)
No information available
Middlemore Hospital, Auckland (New Zealand)
No information available
National Health and Medical Research Council (Australia) - three year project grant (ref: 153711)
No information available
National Health Research Council (New Zealand) (ref: 01/386)
No information available
New South Wales Health Department
No information available
Northern Territory Health Services (Australia) - grant from the Australian Health Care Agreement 1998 - 2003 Quality Improvement and Enhancement Funds
No information available
Queensland Health Services Department (Australia)
No information available
Royal Hobart Hospital, Tasmania (Australia)
No information available
South Australia Department of Human Services (Australia)
No information available
Victoria Department of Human Services (Australia)
No information available
Western Australia Health Department (Australia)
No information available
The SAFE study was initiated and designed by the Australian and New Zealand Intensive Care Society Clinical Trials Group and the Australian and Red Cross Blood Service. The study design, protocol and procedures have been finalised in collaboration with the Institute for International Health, independently of the aforementioned funding bodies. The data will be collected, analysed and published independent of the funding bodies and a copy of the final report will be distributed to them on completion of the study.
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 18/11/2006 | Yes | No | ||
| Results article | 30/08/2007 | Yes | No |
Editorial Notes
08/11/2022: Internal review.
