Comparative Evaluation of the Effect of Theophylline Plus N-acetylcysteine, Theophylline Alone, and N-acetylcysteine Alone in Preventing Contrast-induced Nephropathy in Patients With Moderate to High Risk Undergoing Coronary Angiographic Procedures
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 96
- Locations
- 1
- Primary Endpoint
- Plasma creatinine level
Study Overview
Brief Summary
The aim of this study is to determine the efficacy of Theophylline, N-Acetylcysteine and, and Theophylline plus N-acetylcysteine in the prevention of contrast-induced nephropathy. Investigators assume that Theophylline plus N-acetylcysteine is more effective than Theophylline alone and N-acetylcysteine alone. Investigators include patients referring for elective coronary angiography or angioplasty and allocate them to each of the mentioned treatments from 24 hours before to 48 hours after administration of contrast material. Investigators then measure serum creatinine and see if it is raised by ≥ 0.5 mg/dL or ≥ 25% of the baseline value.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- 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
- •adult patients
- •candidate of elective coronary angiography or angioplasty
- •at least moderate risk for contrast induced nephropathy
Exclusion Criteria
- •unstable angina or myocardial infarction, cardiac arrhythmia, seizures, acute renal failure, end-stage renal disease
- •unstable serum creatinine
- •unstable hemodynamic
- •intravascular administration of contrast material in the past month
- •using theophylline or N-acetylcysteine in the past month,
- •known hypersensitivity to theophylline or N-acetylcysteine
Arms & Interventions
N-acetylcysteine
Patients in the N-acetylcysteine group receive 600 mg non-effervescent N-acetylcysteine tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: N-acetylcysteine (Drug)
N-acetylcysteine
Patients in the N-acetylcysteine group receive 600 mg non-effervescent N-acetylcysteine tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: 0.9% sodium chloride (Drug)
Theophylline
Patients in the Theophylline group receive 200 mg Theophylline slow-release tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: Theophylline (Drug)
Theophylline
Patients in the Theophylline group receive 200 mg Theophylline slow-release tablet plus placebo twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: 0.9% sodium chloride (Drug)
Theophylline plus N-acetylcysteine
Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: N-acetylcysteine (Drug)
Theophylline plus N-acetylcysteine
Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: Theophylline (Drug)
Theophylline plus N-acetylcysteine
Patients in the Theophylline plus N-acetylcysteine group receive Theophylline slow-release 200 mg tablet plus non-effervescent N-acetylcysteine 600 mg tablet twice daily from 24 hours before to 48 hours after administration of contrast material.
Intervention: 0.9% sodium chloride (Drug)
Outcomes
Primary Outcomes
Plasma creatinine level
Time Frame: up to 48h after contrast injection
Plasma creatinine level is measured at baseline and after 48 hours of contrast injection. Increase in plasma creatinine level ≥ 0.5 mg/dL or ≥ 25% of the baseline creatinine after 48 hours of contrast injection will be considered contrast induced nephropathy.
Secondary Outcomes
No secondary outcomes reported
Investigators
Mortaza Arabmomeni
Dr.
Isfahan University of Medical Sciences