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

Contrast-Induced Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02088502
• Other study ID #: 392300
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: March 12, 2014
• Last updated: March 13, 2014
• Start date: September 2013

Study information

• Verified date: March 2014
• Source: Isfahan University of Medical Sciences
• Contact: Mortaza Arabmomeni, M.D.
• Phone: 09131268466
• Email: drmortezaarabmomeni[@]gmail.com
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contrast-Induced Nephropathy
• Kidney Diseases

Intervention

Drug:
• N-acetylcysteine

• Theophylline

• 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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Chamran Hospital	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Albabtain MA, Almasood A, Alshurafah H, Alamri H, Tamim H. Efficacy of ascorbic acid, N-acetylcysteine, or combination of both on top of saline hydration versus saline hydration alone on prevention of contrast-Induced nephropathy: a prospective randomized study. J Interv Cardiol. 2013 Feb;26(1):90-6. doi: 10.1111/j.1540-8183.2012.00767.x. Epub 2012 Sep 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 48h after contrast injection	No