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

Primary Purpose

Contrast Induced Nephropathy

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
sodium bicarbonate
Acetazolamide
normal salin
Sponsored by
Shiraz University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Contrast Induced Nephropathy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fars Heart Foundation , Kowsar hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

1

2

3

Arm Description

150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography

Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography

normal salin 1cc/kg/hr before and after angiography

Outcomes

Primary Outcome Measures

Increased base line creatinine at least 25%

Secondary Outcome Measures

Full Information

First Posted
February 14, 2008
Last Updated
March 4, 2008
Sponsor
Shiraz University of Medical Sciences
Collaborators
Fars Heart Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00634491
Brief Title
Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy
Official Title
Effect of Acetazolamide in Prevention of Contrast Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Shiraz University of Medical Sciences
Collaborators
Fars Heart Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contrast Induced Nephropathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
150 meq/l NaHco3 3cc/kg/hr one Hour before and 1cc/kg/hr 6 hour after angiography
Arm Title
2
Arm Type
Active Comparator
Arm Description
Acetazolamide 250 mg + 1cc/kg/hr normal salin 6 hour before and after angiography
Arm Title
3
Arm Type
Active Comparator
Arm Description
normal salin 1cc/kg/hr before and after angiography
Intervention Type
Drug
Intervention Name(s)
sodium bicarbonate
Other Intervention Name(s)
no other name
Intervention Description
150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox
Intervention Description
Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography
Intervention Type
Drug
Intervention Name(s)
normal salin
Other Intervention Name(s)
no other name
Intervention Description
1 cc/kg/hr 6 hour before and after angiography
Primary Outcome Measure Information:
Title
Increased base line creatinine at least 25%
Time Frame
24 hr later

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maryam Pakfetrat, MD
Organizational Affiliation
Shiraz nephro-urology research center
Official's Role
Study Chair
Facility Information:
Facility Name
Fars Heart Foundation , Kowsar hospital
City
Shiraz
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
16391986
Citation
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. doi: 10.1007/s00246-005-1132-z.
Results Reference
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Comparison Between Effect of Acetazolamide and NaHco3 in Prevention of Contrast Nephropathy

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