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

Renal Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01704482
• Other study ID #: tafanono01003060187
• Status: Completed
• Phase: Phase 2
• First received: October 9, 2012
• Last updated: October 10, 2012
• Start date: February 2011
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiac Surgery for Rheumatic Valvular Heart Disease
• Heart Diseases
• Heart Valve Diseases
• Renal Dysfunction
• Renal Insufficiency
• Rheumatic Diseases
• Rheumatic Heart Disease

Intervention

Drug:
• N-acetylcysteine
NAC 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
• placebo

Locations

Country	Name	City	State
Egypt	Assiut University hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the urinary output		the first five postoperative days	No
Primary	Absolute change in serum creatinine from baseline to peak level		within 5 days after surgery	No
Secondary	the relative change in serum creatinine.		the first five postoperative days	No