Dataset Information

Randomized, placebo-controlled trial of acetaminophen for the reduction of oxidative injury in severe sepsis: the Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis trial.

ABSTRACT:

Objectives

This trial evaluated the efficacy of acetaminophen in reducing oxidative injury, as measured by plasma F2-isoprostanes, in adult patients with severe sepsis and detectable plasma cell-free hemoglobin.

Design

Single-center, randomized, double-blind, placebo-controlled phase II trial.

Setting

Medical ICU in a tertiary, academic medical center.

Patients

Critically ill patients 18 years old or older with severe sepsis and detectable plasma cell-free hemoglobin.

Interventions

Patients were randomized 1:1 to enteral acetaminophen 1 g every 6 hours for 3 days (n = 18) or placebo (n = 22) with the same dosing schedule and duration.

Measurements and main results

F2-Isoprostanes on study day 3, the primary outcome, did not differ between acetaminophen (30 pg/mL; interquartile range, 24-41) and placebo (36 pg/mL; interquartile range, 25-80; p = 0.35). However, F2-isoprostanes were significantly reduced on study day 2 in the acetaminophen group (24 pg/mL; interquartile range, 19-36) when compared with placebo (36 pg/mL; interquartile range, 23-55; p = 0.047). Creatinine on study day 3, a secondary outcome, was significantly lower in the acetaminophen group (1.0 mg/dL; interquartile range, 0.6-1.4) when compared with that in the placebo (1.3 mg/dL; interquartile range, 0.83-2.0; p = 0.039). There was no statistically significant difference in hospital mortality (acetaminophen 5.6% vs placebo 18.2%; p = 0.355) or adverse events (aspartate aminotransferase or alanine aminotransferase > 400; acetaminophen 9.5% vs placebo 4.3%; p = 0.599).

Conclusions

In adults with severe sepsis and detectable plasma cell-free hemoglobin, treatment with acetaminophen within 24 hours of ICU admission may reduce oxidative injury and improve renal function. Additional study is needed to confirm these findings and determine the effect of acetaminophen on patient-centered outcomes.

SUBMITTER: Janz DR

PROVIDER: S-EPMC4336619 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Publications

Randomized, placebo-controlled trial of acetaminophen for the reduction of oxidative injury in severe sepsis: the Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis trial.

Janz David R DR Bastarache Julie A JA Rice Todd W TW Bernard Gordon R GR Warren Melissa A MA Wickersham Nancy N Sills Gillian G Oates John A JA Roberts L Jackson LJ Ware Lorraine B LB

Critical care medicine 20150301 3

<h4>Objectives</h4>This trial evaluated the efficacy of acetaminophen in reducing oxidative injury, as measured by plasma F2-isoprostanes, in adult patients with severe sepsis and detectable plasma cell-free hemoglobin.<h4>Design</h4>Single-center, randomized, double-blind, placebo-controlled phase II trial.<h4>Setting</h4>Medical ICU in a tertiary, academic medical center.<h4>Patients</h4>Critically ill patients 18 years old or older with severe sepsis and detectable plasma cell-free hemoglobin ...[more]

PMID: 25474535

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Dataset Information

Randomized, placebo-controlled trial of acetaminophen for the reduction of oxidative injury in severe sepsis: the Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis trial.

Objectives

Design

Setting

Patients

Interventions

Measurements and main results

Conclusions

Publications

Randomized, placebo-controlled trial of acetaminophen for the reduction of oxidative injury in severe sepsis: the Acetaminophen for the Reduction of Oxidative Injury in Severe Sepsis trial.

Similar Datasets

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