Randomized Controlled Trial Examining the Effect of N-Acetylcysteine on Serum Creatinine in Patients With Stage 3 Chronic Kidney Disease
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- 24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C
Study Overview
Brief Summary
N-acetylcysteine is used to reduce the risk of injury to the kidney after the administration of contrast dye. The mechanism and effectiveness of this intervention is not substantiated in the literature. The investigators hypothesize that serum creatinine will be lower in patients who receive NAC compared to those who receive the placebo but serum cystatin C will not change in patients who receive NAC compared to those who receive the placebo. Also urine creatinine will increase after the administration of NAC compared to before the administration of NAC.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with an eGFR between 30-60 ml/min calculated using last available creatinine and patient weight.
- •No known allergies to or adverse effects from NAC
- •No known scheduled radio-contrast procedures
- •No medications known to affect creatinine secretion
Exclusion Criteria
- Not provided
Arms & Interventions
1
N-acetylcysteine 1200 mg twice daily x 48 hours
Intervention: N-acetylcysteine (Drug)
2
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
24 hour creatinine clearance, estimated glomerular filtration rate (eGFR), proteinuria and cystatin C
Secondary Outcomes
No secondary outcomes reported