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

This study has been completed.

First Received: February 14, 2008 Last Updated: March 4, 2008 History of Changes

Sponsors and Collaborators:	Shiraz University of Medical Sciences Fars Heart Foundation
Information provided by:	Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00634491

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 II

Drug Information available for: Acetazolamide Sodium bicarbonate Acetazolamide sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment
Official Title:	Effect of Acetazolamide in Prevention of Contrast Nephropathy

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
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator normal salin 1cc/kg/hr before and after angiography	Drug: normal salin 1 cc/kg/hr 6 hour before and after angiography

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:

Assadi F. Acetazolamide for prevention of contrast-induced nephropathy: a new use for an old drug. Pediatr Cardiol. 2006 Mar-Apr;27(2):238-42.

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

Study placed in the following topic categories:

Carbonic Anhydrase Inhibitors
Urologic Diseases
Diuretics
Acetazolamide

Cardiovascular Agents
Kidney Diseases
Anticonvulsants

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Acetazolamide
Enzyme Inhibitors
Cardiovascular Agents
Pharmacologic Actions

Carbonic Anhydrase Inhibitors
Urologic Diseases
Natriuretic Agents
Therapeutic Uses
Kidney Diseases
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009