Critical care : the official journal of the Critical Care Forum
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Comment Comparative Study
Conflicting clinical trial data: a lesson from albumin.
Albumin is a frequently prescribed drug in hospitalized patients, and its effect on clinical outcomes has been scrutinized in recent years. Data from meta-analyses has suggested harm related to albumin therapy in critically ill patients, and new observational data are consistent with these results. However, appropriately powered randomized, controlled trials have shown albumin to be safe in broad groups of critically ill patients. This article will discuss the reasons for differences between observational and controlled trial data, and the implications for future albumin use and clinical research.
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Randomized Controlled Trial
Early goal-directed therapy after major surgery reduces complications and duration of hospital stay. A randomised, controlled trial [ISRCTN38797445].
Goal-directed therapy (GDT) has been shown to improve outcome when commenced before surgery. This requires pre-operative admission to the intensive care unit (ICU). In cardiac surgery, GDT has proved effective when commenced after surgery. The aim of this study was to evaluate the effect of post-operative GDT on the incidence of complications and duration of hospital stay in patients undergoing general surgery. ⋯ Post-operative GDT is associated with reductions in post-operative complications and duration of hospital stay. The beneficial effects of GDT may be achieved while avoiding the difficulties of pre-operative ICU admission.
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Severe acute renal failure (sARF) is associated with considerable morbidity, mortality and use of healthcare resources; however, its precise epidemiology and long-term outcomes have not been well described in a non-specified population. ⋯ sARF is common and males, older patients, and those with underlying medical conditions are at greatest risk. Although the majority of patients with sARF will die, most survivors will become independent from renal replacement therapy within a year.
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Human sepsis is an intrinsically complex disease. Populations of patients enrolled into clinical trials of novel sepsis therapies are notoriously heterogeneous with respect to the inciting cause of their disease, the co-morbid conditions that define its course, and the acute severity of their initial presentation. This heterogeneity is reflected in strikingly variable mortality risks across studies, and probably, though less clearly-established, in variable response rates to a given intervention. ⋯ On the other hand, if we view severity as a crude surrogate for a particular pathologic state, we would shift our focus to better defining those populations most likely to benefit from intervention, including patients who may not have met criteria for entry in the original PROWESS trial--those with disseminated intravascular coagulation or acute organ dysfunction from causes other than sepsis. Staging systems that stratify heterogeneous patient populations by risk and by potential to benefit from intervention have proven to be essential to the development of multimodal adjuvant treatment for cancer. They will be no less important in the optimal management of sepsis.
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The Surviving Sepsis Campaign (SSC) is an international effort to reduce mortality in severe sepsis and septic shock. The campaign included the creation of evidence-based guidelines sponsored and endorsed by 11 international organizations. ⋯ In this issue of Critical Care, Gao et al. have evaluated performance at their institution by using a close adaptation of the two SSC bundle sets and demonstrated an association between 100% compliance with the bundle elements and clinical outcome. The next step will be to demonstrate that the use of education and feedback for performance improvement will increase compliance and decrease mortality in the patient population in general.