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FYI... SAFE trial
thought some may find this interesting as the debate of crystalloid versus colloid for resuscitation is always debated....
SCCM: No Survival Difference Noted Between Albumin and Saline Intravenous Resuscitation
By M.M. Pennell
ORLANDO, FL -- February 24, 2004 -- There is no 28-day mortality difference between patients who are resuscitated with albumin or saline, suggest results of the largest randomized trial of intravenous (IV) resuscitation fluids to date.
Simon Finfer, MB BS, MRCP, FRCA, senior staff specialist in Intensive Care at Royal North Shore Hospital, Sydney, Australia, and lead investigator of the Saline versus Albumin Fluid Evaluation (SAFE) trial presented the study's findings at the 33rd Critical Care Congress, the annual meeting of the Society of Critical Care Medicine. He said results of the 7,000 patient study provides the first "evidence that one fluid is not safer than the other in terms of mortality."
Twenty-eight day mortality for patients randomized to albumin was 20.9% while mortality in the saline arm was 21.1%, Dr. Finfer said. "So we can answer the question about difference: there is no difference," he said. The study was powered at 90% to detect a 3% difference in mortality.
Since crystalloid fluids such as saline cost significantly less than albumin and other colloids, which are blood products, the study results could have significant economic impact, said J. Christopher Framer, MD, professor of medicine, pulmonary and critical care medicine at the Mayo Clinic, Rochester, Minnesota, United States.
Dr. Farmer said the trial was "so well done that is it amazing -- to meet the enormous logistical challenge of running a 7,000-patient trial, at so many ICUs and collect all the data in just 18 months. The bottom line is that this is a very clean set of data." He said it is likely to end the colloid-crystalloid debate that has been on-going for 30 to 40 years.
Dr. Farmer was not involved in the study, but he chaired the late-breaking clinical trials session where it was presented and he is a co-chair of this year's Congress.
In addition to providing evidence that colloids and crystalloids are equally effective, the study also "debunked another myth: the three-to-one ratio," said Dr. Farmer. He said that it has been universally accepted that it takes 3 times as much crystalloid volume to resuscitate. But Dr. Finfer said that the actual ratio was 1.38 liters saline to 1 liter albumin. "On average the patients received an average of 1200 mL albumin/day and 1600 mL saline during the initial 4 days," he said.
Data were available on 3,473 patients randomized to albumin and 3,460 patients randomized to saline. Dr. Finfer noted that the 16-center study had "closed the books" in October so "we have only completed the analysis to answer the mortality question."
Nonetheless, he did note that while there was no overall difference in survival there is a slight difference in trauma and head trauma patients that favors saline. Trauma patients resuscitated with albumin had a 1.36 risk for death, so "there was a slight excess death."
The average age of patients in both groups was 58, and 1,424 of the albumin-treated patients were female as were 1,376 of the saline patients.
Dr. Finfer said an essential part of the study was the use of specially designed packaging and tubing. Both albumin and saline were packaged in cardboard sleeves that disguised their contents and the IV tubing was tinted green so that it was impossible to detect a color difference. Dr. Farmer agreed that this unique blinding technique successfully eliminated bias.
The study was supported by Australian and New Zealand Intensive Care Society Clinical Trials Group, the Institute for International Health of the University of Sydney, the Australian Red Cross Blood Service and CSL Limited of Melbourne, which manufactured the IV fluid products used in the study.
[Study title: "Does Albumin Kill? Results of a Randomized Control of 7,000 Patients."]
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