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

Isfahan University of Medical Sciences

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Contrast-Induced Nephropathy

Treatments: Drug: Theophylline; Drug: 0.9% sodium chloride; Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT02088502

392300

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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96 participants in 3 patient groups

N-acetylcysteine

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride

Drug: N-acetylcysteine

Theophylline

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride

Drug: Theophylline

Theophylline plus N-acetylcysteine

Active Comparator group

Description:

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.

Treatment:

Drug: 0.9% sodium chloride

Drug: N-acetylcysteine

Drug: Theophylline