Cardiac Surgery for Rheumatic Valvular Heart Disease, Renal Dysfunction
Conditions
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.
Interventions
DRUGN-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
DRUGplacebo
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change in serum creatinine from baseline to peak level | within 5 days after surgery |
Secondary
| Measure | Time frame |
|---|---|
| the relative change in serum creatinine. | the first five postoperative days |
Other
| Measure | Time frame |
|---|---|
| the urinary output | the first five postoperative days |
Countries
Egypt
Outcome results
None listed