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

Assiut University

Status and phase: Completed; Phase 2

Conditions: Cardiac Surgery for Rheumatic Valvular Heart Disease; Renal Dysfunction

Treatments: Drug: N-acetylcysteine; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01704482

tafanono01003060187

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

N-acetylcysteine

Experimental group

Description:

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

Treatment:

Drug: N-acetylcysteine

Glucose 5%

Placebo Comparator group

Description:

equivalent volume over the same period.

Treatment:

Drug: placebo