Abstract
IntroductionRecombinant human activated protein C (APC) therapy has been shown to reduce short-term mortality in patients with severe sepsis. However, survivors of sepsis may have long-term complications affecting health-related quality of life (HRQoL) and resource utilization. The objective of this study was to evaluate prospectively the effect of APC on long-term HRQoL and resource utilization compared with a nonrandomized control group that received standard care.MethodsThis was an observational cohort study at nine Canadian intensive care units. Patients with severe sepsis who survived to 28 days were recruited. Patients who received APC formed the treatment group and those that did not formed the standard care group. Patients who did not receive APC because of central nervous system bleeding risk were excluded from the standard care group. HRQoL (determined using the 36-item Short Form) and resource use were recorded at 28 days, and 3, 5 and 7 months.ResultsOne hundred patients were enrolled (64 in the standard care group and 36 in the APC group), with 70 patients completing all follow-up visits. Over the 6 months of follow up, APC-treated patients exhibited statistically significantly better scores for the physical component score (P = 0.04) and trends toward improvements in physical functioning (P = 0.12), role physical (P = 0.10) and bodily pain (P = 0.14) as compared with standard care patients. Shorter hospital length of stay was observed for the APC group (36 days versus 48 days; P = 0.05).ConclusionThese findings challenge earlier assumptions suggesting equivalent HRQoL and resource use in APC-treated and standard care patients who survive severe sepsis.
Highlights
Introduction Recombinant human activated proteinC (APC) therapy has been shown to reduce short-term mortality in patients with severe sepsis
Study population Given that randomization of activated protein C (APC) was not possible after publication of the Recombinant Human Activated Protein C Worldwide Evaluation in Severe Sepsis (PROWESS) study, our goal was to develop a prospective cohort of patients who survived
Recombinant human APC effects on long-term health-related quality of life (HRQoL) and resource utilization compared with standard care are largely unknown
Summary
Introduction Recombinant human activated proteinC (APC) therapy has been shown to reduce short-term mortality in patients with severe sepsis. The objective of this study was to evaluate prospectively the effect of APC on long-term HRQoL and resource utilization compared with a nonrandomized control group that received standard care. Several studies have documented that sepsis is associated with increased hospital resource utilization and prolonged intensive care unit (ICU) and hospital stay [2,3,4,5]. With such considerable effects on associated morbidity and mortality, the economic burden associated with sepsis has recently been estimated at 17 billion dollars each year in the USA alone [1]. Patients who survive sepsis often have severely compromised organ function
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