N-acetylcysteine for Renal Protection in Patients With Rheumatic Heart Disease Undergoing Valve Replacement.

Assiut University1 site in 1 country60 target enrollmentFebruary 2011

ConditionsCardiac Surgery for Rheumatic Valvular Heart Disease Renal Dysfunction

InterventionsN-acetylcysteine placebo

DrugsN-acetylcysteine placebo

Overview

Phase: Phase 2
Intervention: N-acetylcysteine
Conditions: Cardiac Surgery for Rheumatic Valvular Heart Disease
Sponsor: Assiut University
Enrollment: 60
Locations: 1
Primary Endpoint: Absolute change in serum creatinine from baseline to peak level
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

We aim to investigate the efficacy of N-acetylcysteine (NAC) to attenuate acute renal dysfunction in patients with rheumatic valvular heart disease undergoing single valve replacement.

Registry

clinicaltrials.gov

Start Date

February 2011

End Date

September 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Assiut University

Responsible Party

Principal Investigator

Mostafa Samy Abbas

assistant lecturer of anesthesia and ICU, Assiut University

Assiut University

Eligibility Criteria

Inclusion Criteria

•patients with rheumatic heart disease undergoing single valve replacement

Exclusion Criteria

•End stage renal disease (plasma creatinine concentration ≥ 300 µmol/L)
•Emergency cardiac surgery
•Planned off-pump cardiac surgery
•Chronic inflammatory disease on immunosuppression
•Chronic moderate to high dose corticosteroid therapy (≥ 10 mg/day prednisone or equivalent)
•Age ≤ 18 years.

Arms & Interventions

N-acetylcysteine

N-acetylcysteine bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs

Intervention: N-acetylcysteine