TY - JOUR
T1 - N-Acetylcysteine for patients with prolonged hypotension as prophylaxis for acute renal failure (NEPHRON)
AU - Komisarof, Jeffrey A.
AU - Gilkey, Gawain M.
AU - Peters, Dawn M.
AU - Koudelka, Caroline W.
AU - Meyer, Mary M.
AU - Smith, Stephen M.
N1 - Copyright:
Copyright 2008 Elsevier B.V., All rights reserved.
PY - 2007/2
Y1 - 2007/2
N2 - 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 ≥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 (≥ 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.
AB - 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 ≥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 (≥ 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.
KW - Acute renal failure
KW - Creatinine
KW - Hypotension
KW - N-acetylcysteine
KW - Oxygen free radicals
KW - Sepsis
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U2 - 10.1097/01.CCM.0000253816.83011.DB
DO - 10.1097/01.CCM.0000253816.83011.DB
M3 - Article
C2 - 17205018
AN - SCOPUS:33846424271
SN - 0090-3493
VL - 35
SP - 435
EP - 441
JO - Critical care medicine
JF - Critical care medicine
IS - 2
ER -