search
Back to results

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

Primary Purpose

Contrast-Induced Nephropathy

Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
N-acetylcysteine
Theophylline
0.9% sodium chloride
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast-Induced Nephropathy focused on measuring Coronary Angiography, Side Effects, Contrast-Induced Nephropathy, Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Chamran HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

N-acetylcysteine

Theophylline

Theophylline plus N-acetylcysteine

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 12, 2014
Last Updated
March 13, 2014
Sponsor
Isfahan University of Medical Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT02088502
Brief Title
Theophylline, N-acetylcysteine, and Theophylline Plus N-acetylcysteine in Preventing Contrast-induced Nephropathy
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 Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Isfahan University of Medical Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast-Induced Nephropathy
Keywords
Coronary Angiography, Side Effects, Contrast-Induced Nephropathy, Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
96 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
N-acetylcysteine
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Theophylline
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Theophylline plus N-acetylcysteine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Type
Drug
Intervention Name(s)
Theophylline
Intervention Type
Drug
Intervention Name(s)
0.9% sodium chloride
Intervention Description
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.
Primary Outcome Measure Information:
Title
Plasma creatinine level
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mortaza Arabmomeni, M.D.
Phone
09131268466
Email
drmortezaarabmomeni@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mortaza Arabmomeni, M.D.
Organizational Affiliation
Isfahan University of Medical Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Chamran Hospital
City
Isfahan
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mortaza Arabmomeni, M.D.
Phone
09131268466
Email
drmortezaarabmomeni@gmail.com
First Name & Middle Initial & Last Name & Degree
Mortaza Arabmomeni, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
22994682
Citation
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.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs