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

NCT02088502 | Unknown Phase 2

• 1 other identifier: 392300
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Contrast-Induced Nephropathy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

N-acetylcysteine

ACTIVE COMPARATOR

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.

Drug: N-acetylcysteine; Drug: 0.9% sodium chloride

Theophylline

ACTIVE COMPARATOR

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.

Drug: Theophylline; Drug: 0.9% sodium chloride

Theophylline plus N-acetylcysteine

ACTIVE COMPARATOR

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.

Drug: N-acetylcysteine; Drug: Theophylline; Drug: 0.9% sodium chloride

Interventions

N-acetylcysteine DRUG

N-acetylcysteine; Theophylline plus N-acetylcysteine

Theophylline DRUG

Theophylline; Theophylline plus N-acetylcysteine

0.9% sodium chloride DRUG

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.

N-acetylcysteine; Theophylline; Theophylline plus N-acetylcysteine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients
• candidate of elective coronary angiography or angioplasty
• at least moderate risk for contrast induced nephropathy

You may not qualify if:

• 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

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Chamran Hospital

Isfahan, Isfahan, Iran

RECRUITING

Related 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.

  PMID: 22994682 BACKGROUND

MeSH Terms

Interventions

Acetylcysteine; Theophylline; Sodium Chloride

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mortaza Arabmomeni, M.D.

  Isfahan University of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Mortaza Arabmomeni, M.D.

CONTACT

09131268466; drmortezaarabmomeni@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: March 12, 2014
• First Posted: March 17, 2014
• Study Start: September 1, 2013
• Primary Completion: April 1, 2014
• Last Updated: March 17, 2014

Record last verified: 2014-03

Locations

IR (1)