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

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

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02088502

Enrollment

Registered

2014-03-17

Start date

2013-09-30

Completion date

Unknown

Last updated

2014-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Contrast-Induced Nephropathy

Keywords

Coronary Angiography, Side Effects, Contrast-Induced Nephropathy, Prevention

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.

Interventions

DRUGN-acetylcysteine

DRUGTheophylline

DRUG0.9% 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Iran

Contacts

Primary ContactMortaza Arabmomeni, M.D.

drmortezaarabmomeni@gmail.com09131268466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026