Saline has similar effect to albumin in critically ill patients
http://www.100md.com
《英国医生杂志》
London
No difference exists in 28 day mortality between patients who are resuscitated with albumin and those given saline. This is the finding of a large randomised trial of fluid resuscitation in critically ill patients, reported at a recent meeting in the United States.
Results from the saline versus albumin fluid evaluation (SAFE) trial of nearly 7000 critically ill patients showed that 28 day mortality for patients randomised to albumin was 20.9%, whereas mortality in the saline arm was 21.1%. Data were available for a total of 3473 patients receiving albumin and 3460 receiving saline; the mean age of patients was 58 years. Although the researchers found no difference in overall survival, they found a slight difference— in favour of saline—in mortality in patients who had trauma and head trauma. The relative risk of death in trauma patients resuscitated with albumin was 1.36.
Simon Finfer, senior staff specialist in intensive care at Royal North Shore Hospital, Sydney, Australia, and lead investigator of the study, said that the results provided the first clear evidence that one fluid was no safer than the other in terms of mortality. "So we can answer the question about difference: there is no difference," he said, reporting the results at the annual meeting of the Society of Critical Care Medicine on 24 February in Orlando, Florida.
Commenting on the results at the meeting, Professor J Christopher Framer, professor of medicine and pulmonary and critical care medicine at the Mayo Clinic, Rochester, Minnesota, said: "The trial was so well done that it is amazing—to meet the enormous logistical challenge of running a 7000 patient trial, at so many and collect all the data in just 18 months. The bottom line is that this is a very clean set of data."
He said that it was likely to end the colloid-crystalloid debate that had been going on for the past 30 to 40 years. Crystalloid fluids such as saline cost significantly less than albumin and other colloids, which are blood products, so the study results could have substantial cost implications.
In addition to providing evidence that colloids and crystalloids were equally effective, the study also debunked another myth: the 3:1 ratio. It had previously been universally accepted that it took three times as much crystalloid (such as saline) volume to resuscitate a patient. But Dr Finfer said that the actual ratio was only 1.38 litres of saline to one litre of albumin. "On average, the patients in the study received an average of 1200 ml albumin a day and 1600 ml saline during the initial four days," he reported.
Results were in line with a previous meta-analysis of 24 studies (comprising 1419 patients) that concluded that there was no evidence that albumin reduced mortality in critically ill patients compared with crystalloid solutions and that there was a strong implication that it might increase the risk of death ( BMJ 1998;317: 235-40).
Subsequent meta-analyses of completed trials had not resolved the clinical uncertainty, and it was widely agreed that a large, high quality, randomised controlled trial of albumin in critically ill patients was needed.(Susan Mayor)
No difference exists in 28 day mortality between patients who are resuscitated with albumin and those given saline. This is the finding of a large randomised trial of fluid resuscitation in critically ill patients, reported at a recent meeting in the United States.
Results from the saline versus albumin fluid evaluation (SAFE) trial of nearly 7000 critically ill patients showed that 28 day mortality for patients randomised to albumin was 20.9%, whereas mortality in the saline arm was 21.1%. Data were available for a total of 3473 patients receiving albumin and 3460 receiving saline; the mean age of patients was 58 years. Although the researchers found no difference in overall survival, they found a slight difference— in favour of saline—in mortality in patients who had trauma and head trauma. The relative risk of death in trauma patients resuscitated with albumin was 1.36.
Simon Finfer, senior staff specialist in intensive care at Royal North Shore Hospital, Sydney, Australia, and lead investigator of the study, said that the results provided the first clear evidence that one fluid was no safer than the other in terms of mortality. "So we can answer the question about difference: there is no difference," he said, reporting the results at the annual meeting of the Society of Critical Care Medicine on 24 February in Orlando, Florida.
Commenting on the results at the meeting, Professor J Christopher Framer, professor of medicine and pulmonary and critical care medicine at the Mayo Clinic, Rochester, Minnesota, said: "The trial was so well done that it is amazing—to meet the enormous logistical challenge of running a 7000 patient trial, at so many and collect all the data in just 18 months. The bottom line is that this is a very clean set of data."
He said that it was likely to end the colloid-crystalloid debate that had been going on for the past 30 to 40 years. Crystalloid fluids such as saline cost significantly less than albumin and other colloids, which are blood products, so the study results could have substantial cost implications.
In addition to providing evidence that colloids and crystalloids were equally effective, the study also debunked another myth: the 3:1 ratio. It had previously been universally accepted that it took three times as much crystalloid (such as saline) volume to resuscitate a patient. But Dr Finfer said that the actual ratio was only 1.38 litres of saline to one litre of albumin. "On average, the patients in the study received an average of 1200 ml albumin a day and 1600 ml saline during the initial four days," he reported.
Results were in line with a previous meta-analysis of 24 studies (comprising 1419 patients) that concluded that there was no evidence that albumin reduced mortality in critically ill patients compared with crystalloid solutions and that there was a strong implication that it might increase the risk of death ( BMJ 1998;317: 235-40).
Subsequent meta-analyses of completed trials had not resolved the clinical uncertainty, and it was widely agreed that a large, high quality, randomised controlled trial of albumin in critically ill patients was needed.(Susan Mayor)