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Completed

NCT Number: NCT00211653

Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery

Completed

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Key information

Conditions

Kidney Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Veterans Affairs Medical Center

Minneapolis, Minnesota, 55417, United States

About this study

Postoperative renal dysfunction is a predictor of significant morbidity and mortality among patients undergoing cardiac surgery. The mortality associated with coronary artery by-pass surgery increases from 2% to almost 19% in patients with renal failure and approaches 60% in patients who require hemodialysis. Patients with preoperative renal dysfunction referred for coronary artery by pass surgery have an extraordinarily high risk of requiring postoperative dialysis. For example, among those patients with preoperative creatinine >2.5 mg/dL, almost 50% require hemodialysis.

Comparison: N-Acetylcysteine is superior to placebo in preventing renal failure after cardiac surgery

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pts with baseline chronic kidney disease (eGFR<60 ml/min/1.73m2)undergoing cardiac surgery

Exclusion criteria

  • Patients on hemodialysis preoperatively
  • IV contrast within 4 days prior to surgery
  • Urgent/emergent surgery
  • History of renal transplantation

Treatment and study plan

N-acetylcysteine

Drug

Primary outcomes

  1. Rise in creatinine above baseline

    Time frame: 7 days postoperatively

Secondary outcomes

  1. Creatinine increase >25% or =/> 0.5 mg/dl above baseline

    Time frame: Postoperative days 5, 7 and 30

  2. Length of stay in the ICU and the hospital

  3. Operative mortality

    Time frame: 30-day

Sponsors and collaborators

Lead sponsor

Minneapolis Veterans Affairs Medical Center

Fed

Registry information

Official study title

Single Center Randomized Clinical Trial of the Effects of Acetylcysteine in the Prevention of Postoperative Renal Failure

Important dates

Study start
2003
Study completion
2006
First posted
Sep 21, 2005
Registry last updated
Sep 19, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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