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

March 4, 2008 updated by: Shiraz University of Medical Sciences

Effect of Acetazolamide in Prevention of Contrast Nephropathy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • no other name

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Increased base line creatinine at least 25%
Time Frame: 24 hr later
24 hr later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Collaborators

Fars Heart Foundation

Investigators

  • Study Chair: Maryam Pakfetrat, MD, Shiraz nephro-urology research center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

February 1, 2008

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

February 14, 2008

First Submitted That Met QC Criteria

March 4, 2008

First Posted (Estimate)

March 13, 2008

Study Record Updates

Last Update Posted (Estimate)

March 13, 2008

Last Update Submitted That Met QC Criteria

March 4, 2008

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2438

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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