Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy - Tabular View

Tracking Information

First Received Date ^ICMJE

February 14, 2008

Last Updated Date

March 4, 2008

Start Date ^ICMJE

September 2007

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00634491 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Effect of Acetazolamide in Prevention of Contrast Nephropathy

Brief Summary

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment

Condition ^ICMJE

Contrast Induced Nephropathy

Intervention ^ICMJE

Drug: sodium bicarbonate
Drug: Acetazolamide
Drug: normal salin

Study Arms / Comparison Groups

Active Comparator: 150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography
Active Comparator: Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography
Active Comparator: normal salin 1cc/kg/hr before and after angiography

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT ID ^ICMJE

NCT00634491

Responsible Party

Office of Vice Chancellor for research in Shiraz UMS, Shiraz University of Medical Science

Study ID Numbers ^ICMJE

2438

Study Sponsor ^ICMJE

Shiraz University of Medical Sciences

Collaborators ^ICMJE

Fars Heart Foundation

Investigators ^ICMJE

Study Chair:

Maryam Pakfetrat, MD

Shiraz nephro-urology research center

Information Provided By

Shiraz University of Medical Sciences

Verification Date

March 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP