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

Phase 2

• Conditions: Contrast-Induced Nephropathy
• Interventions: Drug: N-acetylcysteine; Drug: Theophylline; Drug: 0.9% sodium chloride

• Registration Number: NCT02088502
• Lead Sponsor: Isfahan University of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Status Verified: 2014-03
• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-13
• Last Update Submitted: 2014-03-13
• Study First Posted: 2014-03-17
• Last Update Posted: 2014-03-17
• Primary Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Theophylline plus N-acetylcysteine	0.9% sodium chloride	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.
N-acetylcysteine	0.9% sodium chloride	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.
Theophylline	0.9% sodium chloride	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.
N-acetylcysteine	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.
Theophylline	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.
Theophylline plus N-acetylcysteine	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.
Theophylline plus N-acetylcysteine	Theophylline	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.

Primary Outcome Measures

Name	Time	Method
Plasma creatinine level	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.

Trial Locations

Locations (1)

Chamran Hospital; 🇮🇷 Isfahan, Iran, Islamic Republic of