Effect of baseline serum albumin concentration on outcome of resuscitation with albumin or saline in patients in intensive care units: analysis of data from the saline versus albumin fluid evaluation (SAFE) studyBMJ 2006; 333 doi: https://doi.org/10.1136/bmj.38985.398704.7C (Published 16 November 2006) Cite this as: BMJ 2006;333:1044
- SAFE Study Investigators
- Correspondence to: Professor S Finfer, Australian and New Zealand Intensive Care Society Clinical Trials Group, Carlton, Vic 3053, Australia
- Accepted 12 September 2006
Objective To determine whether outcomes of resuscitation with albumin or saline in the intensive care unit depend on patients' baseline serum albumin concentration.
Design Analysis of data from a double blind, randomised controlled trial.
Setting Intensive care units of 16 hospitals in Australia and New Zealand.
Participants 6045 participants in the saline versus albumin fluid evaluation (SAFE) study.
Interventions Fluid resuscitation with 4% albumin or saline in patients with a baseline serum albumin concentration of 25 g/l or less or more than 25 g/l.
Main outcome measures Primary outcome was all cause mortality at 28 days. Secondary outcomes were length of stay in the intensive care unit, length of stay in hospital, duration of renal replacement therapy, and duration of mechanical ventilation.
Main results The odds ratios for death for albumin compared with saline for patients with a baseline serum albumin concentration of 25 g/l or less and more than 25 g/l were 0.87 and 1.09, respectively (ratio of odds ratios 0.80, 95% confidence interval 0.63 to 1.02); P=0.08 for heterogeneity. No significant interaction was found between baseline serum albumin concentration as a continuous variable and the effect of albumin and saline on mortality. No consistent interaction was found between baseline serum albumin concentration and treatment effects on length of stay in the intensive care unit, length of hospital stay, duration of renal replacement therapy, or duration of mechanical ventilation.
Conclusion The outcomes of resuscitation with albumin and saline are similar irrespective of patients' baseline serum albumin concentration.
Trial registration ISRCTN76588266.
Contributors: Investigators for the saline versus albumin fluid evaluation study are: writing committee—Simon Finfer (chair), Rinaldo Bellomo, Suzanne McEvoy, Sing Kai Lo, John Myburgh, Bruce Neal, and Robyn Norton; management committee—Robyn Norton (chair), Julie French (senior project manager), Rinaldo Bellomo, Simon Finfer, John Myburgh, Suzanne McEvoy, Gordon Doig, Mary Hayek, and Sheridan O'Donnell; steering committee—Simon Finfer (chair), Anthony Bell, Rinaldo Bellomo, Neil Boyce, David Blythe, John Cade, Marianne Chapman, Louise Cole, James Cooper, Andrew Davies, Craig French, Julie French, Christopher Joyce, Colin McArthur, Stephen MacMahon, John Myburgh, Bruce Neal, Robyn Norton, Jeffrey Presneill, Peter Saul, Ian Seppelt, Dianne Stephens, Andrew Turner, Anthony Williams, and Clive Woolfe; and external safety and data monitoring committee—Richard Peto (chair), Peter Sandercock, Charles Sprung, and J Duncan Young. The statistical analysis was carried out by Sing Kai Lo, Siva Sivarajasingham, Lesley Francis, and Mark Woodward (George Institute for International Health, University of Sydney, NSW). The site investigators were: Julie Charlton, James Cooper, Andrew Davies, Catherine Harry, Lisa Higgins, Katherine Moulden, and Shirley Vallance (Alfred Hospital, Melbourne, Vic); Janine Chadderton, Lynette Newby, and Colin McArthur (Auckland Hospital, New Zealand); Samantha Bates, Rinaldo Bellomo, Donna Goldsmith, and Alison Voss (Austin and Repatriation Medical Centre, Melbourne, Vic); Neil Boyce (Australian Red Cross Blood Service, Melbourne, Vic); David Blythe and Annamaria Palermo (Fremantle Hospital, WA); Lesley Francis, Julie French, Mary Hayek, Kathy Jayne, Stephen MacMahon, Mamta Merai, Bruce Neal, Robyn Norton, Sameer Pandey, Sheridan O'Donnell, Manuela Schmidt, Siva Sivarajasingham, and Mark Woodward (George Institute for International Health, University of Sydney, NSW); Rosemary Carroll, Brett McFadyen, and Peter Saul (John Hunter Hospital, Newcastle, NSW); Jane Clarke, Juliet Powell, Anthony Williams, and Judi Tai (Middlemore Hospital, Auckland, New Zealand); Louise Cole, Iveta Hynesova, Ian Seppelt, and Leonie Weisbrodt (Nepean Hospital, Penrith, NSW); Lisa Bradley, Christopher Joyce, Theresa Kelly, Anthony Limpus, and Robyn Moore (Princess Alexandra Hospital, Brisbane, Qld); Marianne Chapman, Stephanie Creed, Sandra Kaplan, and Justine Rivett (Royal Adelaide Hospital, SA); Dianne Stephens and Jane Thomas (Royal Darwin Hospital, NT); Anthony Bell, Kathy Marsden, and Andrew Turner (Royal Hobart Hospital, Tas); Catherine Boyce, John Cade, Belinda Howe, Jeffrey Presneill, and Megan Robertson (Royal Melbourne Hospital, Vic); Gordon Doig, Simon Finfer, Anne O'Connor, Julie Potter, and Naresh Ramakrishnan (Royal North Shore Hospital, Sydney, NSW); Catherine Powell, Dorrilyn Rajbhandari, and Clive Woolfe (Royal Prince Alfred Hospital, Sydney, NSW); Kathryn Girling, Marie Hodgetts, Alina Jovanovska, and John Myburgh (St George Hospital, Sydney, NSW); and Craig French and Lorraine Little (Western Hospital, Melbourne, Vic). The saline versus albumin fluid evaluation study is a collaboration of the Australian and New Zealand Intensive Care Society Clinical Trials Group, the Australian Red Cross Blood Service, and the George Institute for International Health. The writing committee will act as guarantor.
Funding: Auckland District Health Board, New Zealand; Australian Commonwealth Department of Health and Aged Care; CSL, Melbourne, Victoria; Middlemore Hospital, New Zealand; Australian National Health and Medical Research Council; Health Department of Western Australia; Health Research Council of New Zealand; New South Wales Health Department; Northern Territory Health Services; Queensland Health Services Department; Royal Hobart Hospital, Tasmania; South Australian Department of Human Services; and Victorian Department of Human Services
Competing interests: The saline versus albumin fluid evaluation study was part funded by CSL. CSL has acted as a sponsor for scientific meetings of the Australian and New Zealand Intensive Care Society and its clinical trials group. CSL has paid travel expenses for Simon Finfer and Rinaldo Bellomo to present the results of the SAFE study at scientific and industry sponsored meetings. Andrew Davies and Diane Stephens own shares in CSL.
Ethical approval: This study was approved by the ethics committees of the University of Sydney and of each of the participating institutions.