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Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Primary Purpose

Kidney Failure

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

N-Acetylcysteine

About this trial

This is an interventional treatment trial for Kidney Failure focused on measuring Kidney failure, Thoracic surgery, Acetylcysteine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Veterans Affairs Medical Center

Outcomes

Primary Outcome Measures

Rise in creatinine above baseline

Secondary Outcome Measures

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

Length of stay in the ICU and the hospital

Operative mortality

Full Information

NCT ID

NCT00211653

First Posted

September 13, 2005

Last Updated

September 18, 2007

Sponsor

Minneapolis Veterans Affairs Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00211653

Brief Title

Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2007

Overall Recruitment Status

Completed

Study Start Date

April 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Minneapolis Veterans Affairs Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Failure

Keywords

Kidney failure, Thoracic surgery, Acetylcysteine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

102 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

N-Acetylcysteine

Primary Outcome Measure Information:

Title

Rise in creatinine above baseline

Time Frame

7 days postoperatively

Secondary Outcome Measure Information:

Title

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

Time Frame

Postoperative days 5, 7 and 30

Title

Length of stay in the ICU and the hospital

Title

Operative mortality

Time Frame

30-day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Selcuk Adabag, MD

Organizational Affiliation

Minneapolis Veterans Affairs Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Veterans Affairs Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55417

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

18513531

Citation

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.

Results Reference

derived

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Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

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