Kidney Failure
Conditions
Keywords
Kidney failure, Thoracic surgery, Acetylcysteine
Brief summary
The purpose of this study is to determine if Acetylcysteine is effective in preventing renal failure associated with cardiac surgery
Detailed description
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
Interventions
DRUGN-Acetylcysteine
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rise in creatinine above baseline | 7 days postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Creatinine increase >25% or =/> 0.5 mg/dl above baseline | Postoperative days 5, 7 and 30 |
| Length of stay in the ICU and the hospital | — |
| Operative mortality | 30-day |
Countries
United States
Outcome results
None listed