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

Phase 2

Completed

• Conditions: Cardiac Surgery for Rheumatic Valvular Heart Disease; Renal Dysfunction
• Interventions: Drug: placebo; Drug: N-acetylcysteine

• Registration Number: NCT01704482
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Study First Submitted: 2012-10-09
• Study First Submitted QC: 2012-10-10
• Last Update Submitted: 2012-10-10
• Study First Posted: 2012-10-11
• Last Update Posted: 2012-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Glucose 5%	placebo	equivalent volume over the same period.
N-acetylcysteine	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

Primary Outcome Measures

Name	Time	Method
Absolute change in serum creatinine from baseline to peak level	within 5 days after surgery

Secondary Outcome Measures

Name	Time	Method
the relative change in serum creatinine.	the first five postoperative days

Trial Locations

Locations (1)

Assiut University hospital; 🇪🇬 Assiut, Egypt