NCT00211653

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Apr 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
Last Updated

September 19, 2007

Status Verified

September 1, 2007

First QC Date

September 13, 2005

Last Update Submit

September 18, 2007

Conditions

Kidney Failure

Keywords

Kidney failureThoracic surgeryAcetylcysteine

Outcome Measures

Primary Outcomes (1)

  • Rise in creatinine above baseline

    7 days postoperatively

Secondary Outcomes (3)

  • 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

Interventions

N-AcetylcysteineDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veterans Affairs Medical Center

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (1)

  • 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.

    PMID: 18513531DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Selcuk Adabag, MD

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

April 1, 2003

Study Completion

November 1, 2006

Last Updated

September 19, 2007

Record last verified: 2007-09

Locations

US(1)