Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Contrast-Induced Nephropathy

Intervention / Treatment
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* Drug: N-acetylcysteine
* Drug: Theophylline
* Drug: 0.9% sodium chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-acetylcysteine<br>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. | Drug: N-acetylcysteine<br> <br> Drug: 0.9% sodium chloride<br>* All patients are hydrated with 0.9% sodium chloride (1 mL/kg/hour) for 24 hours, 12 hours before operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg per hour.<br>|
| Active Comparator: Theophylline<br>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. | Drug: Theophylline<br> <br> Drug: 0.9% sodium chloride<br>* All patients are hydrated with 0.9% sodium chloride (1 mL/kg/hour) for 24 hours, 12 hours before operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg per hour.<br>|
| Active Comparator: Theophylline plus N-acetylcysteine<br>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. | Drug: N-acetylcysteine<br> <br> Drug: Theophylline<br> <br> Drug: 0.9% sodium chloride<br>* All patients are hydrated with 0.9% sodium chloride (1 mL/kg/hour) for 24 hours, 12 hours before operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg per hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma creatinine level | 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. | up to 48h after contrast injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronary Angiography, Side Effects, Contrast-Induced Nephropathy, Prevention