Acetylcysteine in the Prevention of Renal Failure After B... | NCT00211653

Studies
Acetylcysteine in the Prevention of Renal Failure After Bypass Surgery

NCT00211653

Sponsor

Minneapolis Veterans Affairs Medical Center

Status

Completed

Last Update Posted

Sep 19, 2007Estimated

Enrollment

102Actual

Phase

Phase 1Phase 2

Conditions

Kidney Failure

Interventions

N-Acetylcysteine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2003

Primary Completion Date

Not provided

Completion Date

Nov 2006Actual

First Submitted Date

Sep 13, 2005

First Submission Date that Met QC Criteria

Sep 13, 2005

First Posted Date

Sep 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2007

Last Update Posted Date

Sep 19, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Name	Type	Description	Arm Group Labels	Other Names
N-Acetylcysteine	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rise in creatinine above baseline		7 days postoperatively

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Selcuk Adabag, MD	Minneapolis Veterans Affairs Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Veterans Affairs Medical Center		Minneapolis	Minnesota	55417	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18513531	Derived	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.

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

ID	Term
D003545	Cysteine
D000603	Amino Acids, Sulfur
D013457	Sulfur Compounds
D009930	Organic Chemicals