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

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ClinicalTrials.gov Identifier: NCT02088502
Recruitment Status : Unknown
Verified March 2014 by Mortaza Arabmomeni, Isfahan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Information provided by (Responsible Party):
Mortaza Arabmomeni, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Contrast-Induced Nephropathy Drug: N-acetylcysteine Drug: Theophylline Drug: 0.9% sodium chloride Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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 Start Date : September 2013
Estimated Primary Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Active Comparator: N-acetylcysteine
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
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.

Active Comparator: Theophylline
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
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.

Active Comparator: Theophylline plus N-acetylcysteine
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
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 Measures :
  1. Plasma creatinine level [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088502


Contacts
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Contact: Mortaza Arabmomeni, M.D. 09131268466 drmortezaarabmomeni@gmail.com

Locations
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Iran, Islamic Republic of
Chamran Hospital Recruiting
Isfahan, Iran, Islamic Republic of
Contact: Mortaza Arabmomeni, M.D.    09131268466    drmortezaarabmomeni@gmail.com   
Principal Investigator: Mortaza Arabmomeni, M.D.         
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Director: Mortaza Arabmomeni, M.D. Isfahan University of Medical Sciences

Publications:
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Responsible Party: Mortaza Arabmomeni, Dr., Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02088502     History of Changes
Other Study ID Numbers: 392300
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by Mortaza Arabmomeni, Isfahan University of Medical Sciences:
Coronary Angiography
Side Effects
Contrast-Induced Nephropathy
Prevention

Additional relevant MeSH terms:
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Kidney Diseases
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Theophylline
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Vasodilator Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents