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

Sponsor

Isfahan University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02088502

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contrast-Induced Nephropathy	Drug: N-acetylcysteine Drug: Theophylline Drug: 0.9% sodium chloride	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

96 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Sep 1, 2013

Anticipated Primary Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: N-acetylcysteine Drug: 0.9% sodium chloride 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.
Active Comparator: 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.	Drug: Theophylline Drug: 0.9% sodium chloride 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.
Active Comparator: 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.	Drug: N-acetylcysteine Drug: Theophylline Drug: 0.9% sodium chloride 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: N-acetylcysteine

Drug: 0.9% sodium chloride

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.

Active Comparator: 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.

Drug: Theophylline

Drug: 0.9% sodium chloride

Active Comparator: 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.

Drug: N-acetylcysteine

Drug: Theophylline

Drug: 0.9% sodium chloride

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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