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

NCT ID: NCT00634491

Last Updated: 2008-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-02-29

Brief Summary

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

Detailed Description

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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.

Conditions

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Contrast Induced Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

sodium bicarbonate

Intervention Type DRUG

150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography

2

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

Group Type ACTIVE_COMPARATOR

Acetazolamide

Intervention Type DRUG

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

3

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

Group Type ACTIVE_COMPARATOR

normal salin

Intervention Type DRUG

1 cc/kg/hr 6 hour before and after angiography

Interventions

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sodium bicarbonate

150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography

Intervention Type DRUG

Acetazolamide

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

Intervention Type DRUG

normal salin

1 cc/kg/hr 6 hour before and after angiography

Intervention Type DRUG

Other Intervention Names

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no other name Diamox no other name

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fars Heart Foundation

UNKNOWN

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shiraz University of Medical Science

Principal Investigators

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Maryam Pakfetrat, MD

Role: STUDY_CHAIR

Shiraz nephro-urology research center

Locations

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Fars Heart Foundation , Kowsar hospital

Shiraz, , Iran

Site Status

Countries

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Iran

References

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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.

Reference Type RESULT
PMID: 16391986 (View on PubMed)

Other Identifiers

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2438

Identifier Type: -

Identifier Source: org_study_id

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