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N-acetylcysteine for patients with prolonged hypotension as prophylaxis for acute renal failure (NEPHRON).

AbstractBACKGROUND:
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.
AuthorsJeffrey A Komisarof, Gawain M Gilkey, Dawn M Peters, Caroline W Koudelka, Mary M Meyer, Stephen M Smith
JournalCritical care medicine (Crit Care Med) Vol. 35 Issue 2 Pg. 435-41 (Feb 2007) ISSN: 0090-3493 [Print] United States
PMID17205018 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
Chemical References
  • Free Radical Scavengers
  • Acetylcysteine
Topics
  • Acetylcysteine (therapeutic use)
  • Acute Kidney Injury (etiology, prevention & control)
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Double-Blind Method
  • Female
  • Free Radical Scavengers (therapeutic use)
  • Humans
  • Hypotension (complications)
  • Intensive Care Units
  • Male
  • Middle Aged
  • Prospective Studies
  • Time Factors

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