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Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy

This study has been completed.
Sponsor:
Collaborator:
Fars Heart Foundation
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00634491
First received: February 14, 2008
Last updated: March 4, 2008
Last verified: March 2008
History of Changes
  Purpose

The purpose of this study is whether Acetazolamide is effective in prevention of contrast nephropathy


Condition Intervention Phase
Contrast Induced Nephropathy
 Drug: sodium bicarbonate
Drug: Acetazolamide
Drug: normal salin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Acetazolamide in Prevention of Contrast Nephropathy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • Increased base line creatinine at least 25% [ Time Frame: 24 hr later ] [ Designated as safety issue: No ]

Enrollment: 240
Study Start Date: September 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography
 Drug: sodium bicarbonate
150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography
Other Name: no other name
Active Comparator: 2
Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography
 Drug: Acetazolamide
Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography
Other Name: Diamox
Active Comparator: 3
normal salin 1cc/kg/hr before and after angiography
 Drug: normal salin
1 cc/kg/hr 6 hour before and after angiography
Other Name: no other name

Detailed Description:

Contrast induced nephropathy is one of common causes of acute renal failure many preventive protocol existed . 240 patient that underwent coronary angiography randomly divided in three groups.Group 1,2,3 will receive Bicarbonate ,Acetazolamide+Normal salin and Normal salin respectively.We compare prevalence of contrast nephropathy in each group.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patient that underwent coronary angiography

Exclusion Criteria:

  • serum Cr. more than 3 mg/dl
  • electrolyte and acid-base imbalance
  • pulmonary edema
  • allergy to Acetazolamide
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00634491

Locations
Iran, Islamic Republic of
Fars Heart Foundation , Kowsar hospital
Shiraz, Iran, Islamic Republic of
Sponsors and Collaborators
Shiraz University of Medical Sciences
Fars Heart Foundation
Investigators
Study Chair: Maryam Pakfetrat, MD Shiraz nephro-urology research center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Office of Vice Chancellor for research in Shiraz UMS, Shiraz University of Medical Science
ClinicalTrials.gov Identifier: NCT00634491     History of Changes
Other Study ID Numbers: 2438
Study First Received: February 14, 2008
Last Updated: March 4, 2008
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Kidney Diseases
Urologic Diseases
Acetazolamide
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
 Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 16, 2013