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

Phase 3UnknownNCT02088502

Isfahan University of Medical Sciences96 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Contrast-Induced Nephropathy

Interventions

0.9% sodium chlorideDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: up to 48h after contrast injection