Abstract | BACKGROUND: OBJECTIVE: 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 | Jeffrey A Komisarof, Gawain M Gilkey, Dawn M Peters, Caroline W Koudelka, Mary M Meyer, Stephen M Smith |
Journal | Critical care medicine
(Crit Care Med)
Vol. 35
Issue 2
Pg. 435-41
(Feb 2007)
ISSN: 0090-3493 [Print] United States |
PMID | 17205018
(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
|