Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy
Information source: Isfahan University of Medical Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contrast-Induced Nephropathy
Intervention: N-acetylcysteine (Drug); Theophylline (Drug); 0.9% sodium chloride (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Isfahan University of Medical Sciences Official(s) and/or principal investigator(s): Mortaza Arabmomeni, M.D., Study Director, Affiliation: Isfahan University of Medical Sciences
Overall contact: Mortaza Arabmomeni, M.D., Phone: 09131268466, Email: drmortezaarabmomeni@gmail.com
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: Plasma creatinine level
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Mortaza Arabmomeni, M.D., Phone: 09131268466, Email: drmortezaarabmomeni@gmail.com
Chamran Hospital, Isfahan, Iran, Islamic Republic of; Recruiting Mortaza Arabmomeni, M.D., Phone: 09131268466, Email: drmortezaarabmomeni@gmail.com Mortaza Arabmomeni, M.D., Principal Investigator
Additional Information
Related publications: 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.
Starting date: September 2013
Last updated: March 13, 2014
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