NCT00190034

Brief Summary

The purpose of this study is to determine whether N-acetylcysteine is effective in the prophylaxis of post-cardiopulmonary bypass acute renal impairment.

Trial Health

33
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2005

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
suspended

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

January 1, 2005

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

February 9, 2009

Status Verified

June 1, 2006

First QC Date

September 11, 2005

Last Update Submit

February 6, 2009

Conditions

Cardiovascular DiseaseRenal Insufficiency, AcuteCardiopulmonary Bypass

Keywords

Acetylcysteinecardiac surgerycardiopulmonary bypassacute renal insufficiency

Outcome Measures

Primary Outcomes (1)

  • Serum creatinine and blood urea nitrogen: before, 48 h and 5 days after the operation procedure.

Interventions

N-Acetylcysteine 600mg/tabDRUG

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who will received cardiac surgery with cardiopulmonary bypass

You may not qualify if:

  • Dialyzed patients
  • Acute renal failure
  • Advanced left ventricular systolic dysfunction defined as left ventricular ejection fraction ≦ 35%.
  • Acute chronic obstructive lung disease or asthma exacerbation
  • Allergy to N-acetylcysteine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Far Eastern Memorial Hospital

Banqiao District, Taipei, 220, Taiwan

Location

MeSH Terms

Conditions

Cardiovascular DiseasesAcute Kidney Injury

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney 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

  • Shao-jung Li, M.D.

    Far Eastern Memorial Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

January 1, 2005

Study Completion

June 1, 2007

Last Updated

February 9, 2009

Record last verified: 2006-06

Locations

TW(1)