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Acronym | Citation | Summary | Internal Validity | Strengths | Limitations | Significance |
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SAFE | Finfer S, et al. A Comparison of Albumin and Saline for Fluid Resuscitation in the Intensive Care Unit. N Engl J Med 2004;350:2247-2256. | The SAFE trial was a multi-centre, parallel group, randomised controlled trial of 6% albumin solution versus saline in 6,997 critically ill adult patients. The primary outcome was mortality at 28 days. There was no significant difference in mortality between the two groups (relative risk, 0.98; 95% CI, 0.91 to 1.06; P=0.57). | The internal validity of the trial was high, with a large sample size, adequate randomisation and blinding, and low attrition. | The strengths of the trial included its large sample size and rigorous methodology. The trial was conducted in a variety of centres worldwide, increasing its external validity. | Limitations of the trial included the relatively low volume of albumin administered, which may not have been clinically significant, and the lack of blinding in the use of rescue therapies. | The SAFE trial demonstrated no difference in mortality between albumin and saline solutions in critically ill patients, calling into question the widespread use of albumin in resuscitation. |