Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-11-30

Brief Summary

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

Detailed Description

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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

Conditions

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Kidney Failure

Keywords

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Kidney failure Thoracic surgery Acetylcysteine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Interventions

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N-Acetylcysteine

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Selcuk Adabag, MD

Role: PRINCIPAL_INVESTIGATOR

Minneapolis Veterans Affairs Medical Center

Locations

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Veterans Affairs Medical Center

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

References

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Adabag AS, Ishani A, Koneswaran S, Johnson DJ, Kelly RF, Ward HB, McFalls EO, Bloomfield HE, Chandrashekhar Y. Utility of N-acetylcysteine to prevent acute kidney injury after cardiac surgery: a randomized controlled trial. Am Heart J. 2008 Jun;155(6):1143-9. doi: 10.1016/j.ahj.2008.01.013. Epub 2008 Mar 5.

Reference Type DERIVED

PMID: 18513531 (View on PubMed)

Other Identifiers

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3212-B

Identifier Type: -

Identifier Source: org_study_id