BACKGROUND:Acute renal failure is a common complication in critically ill patients and carries an increased morbidity and mortality. N-acetylcysteine is an antioxidant and anti-inflammatory agent that may counteract some of the pathophysiologic derangements in shock states. OBJECTIVE: To test whether the administration of N-acetylcysteine, compared with placebo, reduces the incidence of acute renal failure in hypotensive patients. DESIGN: Prospective, randomized, double-blinded, placebo-controlled study. SETTING:Intensive care units of a university tertiary care hospital. PATIENTS: One hundred forty-two patients with new onset (within 12 hrs) of at least>or=30 consecutive minutes of hypotension and/or vasopressor requirement. INTERVENTIONS: Patients were randomized to receive either N-acetylcysteine or placebo for 7 days, in addition to standard supportive therapy. MEASUREMENTS AND MAIN RESULTS: Patients who received N-acetylcysteine had an incidence of acute renal failure (>or=0.5 mg/dL increase in creatinine) of 15.5%, compared with 16.9% in those receiving placebo (p=.82, not significant). There were no significant differences between treatment arms in any of the secondary outcomes examined, including incidence of a 50% increase in creatinine, maximal rise in creatinine, recovery of renal function, length of intensive care unit and hospital stay, requirement for renal replacement therapy, and mortality. Among patients receiving N-acetylcysteine, there were trends toward reduced incidence of acute renal failure in patients with baseline Sequential Organ Failure Assessment (SOFA) score>8 (p=.12), lower SOFA scores during the first 4 days of treatment (p=.28), and reduced mortality in patients<65 yrs of age (p=.20). CONCLUSIONS: There were no significant differences in any of our primary or secondary end points between patients treated with N-acetylcysteine or placebo. Trends toward reduced incidence of acute renal failure in patients with baseline SOFA score >8, reduced SOFA scores during the first 4 days, and reduced mortality in patients<65 yrs of age are provocative but require further study to determine their clinical significance.
RCT Entities:
BACKGROUND:Acute renal failure is a common complication in critically illpatients and carries an increased morbidity and mortality. N-acetylcysteine is an antioxidant and anti-inflammatory agent that may counteract some of the pathophysiologic derangements in shock states. OBJECTIVE: To test whether the administration of N-acetylcysteine, compared with placebo, reduces the incidence of acute renal failure in hypotensivepatients. DESIGN: Prospective, randomized, double-blinded, placebo-controlled study. SETTING: Intensive care units of a university tertiary care hospital. PATIENTS: One hundred forty-two patients with new onset (within 12 hrs) of at least>or=30 consecutive minutes of hypotension and/or vasopressor requirement. INTERVENTIONS:Patients were randomized to receive either N-acetylcysteine or placebo for 7 days, in addition to standard supportive therapy. MEASUREMENTS AND MAIN RESULTS:Patients who received N-acetylcysteine had an incidence of acute renal failure (>or=0.5 mg/dL increase in creatinine) of 15.5%, compared with 16.9% in those receiving placebo (p=.82, not significant). There were no significant differences between treatment arms in any of the secondary outcomes examined, including incidence of a 50% increase in creatinine, maximal rise in creatinine, recovery of renal function, length of intensive care unit and hospital stay, requirement for renal replacement therapy, and mortality. Among patients receiving N-acetylcysteine, there were trends toward reduced incidence of acute renal failure in patients with baseline Sequential Organ Failure Assessment (SOFA) score>8 (p=.12), lower SOFA scores during the first 4 days of treatment (p=.28), and reduced mortality in patients<65 yrs of age (p=.20). CONCLUSIONS: There were no significant differences in any of our primary or secondary end points between patients treated with N-acetylcysteine or placebo. Trends toward reduced incidence of acute renal failure in patients with baseline SOFA score >8, reduced SOFA scores during the first 4 days, and reduced mortality in patients<65 yrs of age are provocative but require further study to determine their clinical significance.
Authors: Jonathan Himmelfarb; Michael Joannidis; Bruce Molitoris; Miet Schietz; Mark D Okusa; David Warnock; Franco Laghi; Stuart L Goldstein; Richard Prielipp; Chirag R Parikh; Neesh Pannu; Suzana M Lobo; Sudhir Shah; Vincent D'Intini; John A Kellum Journal: Clin J Am Soc Nephrol Date: 2008-03-19 Impact factor: 8.237
Authors: Michael Joannidis; Wilfred Druml; Lui G Forni; A B Johan Groeneveld; Patrick Honore; Heleen M Oudemans-van Straaten; Claudio Ronco; Marie R C Schetz; Arend Jan Woittiez Journal: Intensive Care Med Date: 2010-03 Impact factor: 17.440
Authors: Josh Hanson; Md Mahtab Uddin Hasan; Annick A Royakkers; Shamsul Alam; Prakaykaew Charunwatthana; Richard J Maude; Sam T Douthwaite; Emran Bin Yunus; Murty L Mantha; Marcus J Schultz; M Abul Faiz; Nicholas J White; Nicholas P Day; Arjen M Dondorp Journal: Malar J Date: 2011-08-03 Impact factor: 2.979