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

Assiut University60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Cardiac Surgery for Rheumatic Valvular Heart Disease Renal Dysfunction

Interventions

N-acetylcysteineDRUG

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

placeboDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Assiut University hospital

Asyut, Egypt

Outcomes

Primary Outcomes

Absolute change in serum creatinine from baseline to peak level

Time frame: within 5 days after surgery

Secondary Outcomes

the relative change in serum creatinine.

Time frame: the first five postoperative days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.