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CompletedNCT00634491Updated Mar 13, 2008

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

A Phase 2 interventional study of sodium bicarbonate and Acetazolamide in Contrast Induced Nephropathy, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-03-13.

Sponsored by Shiraz University of Medical Sciences · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Contrast Induced Nephropathy

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03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 240 is above the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • patient that underwent coronary angiography

Exclusion criteria

Exclusion Criteria:

  • serum Cr. more than 3 mg/dl
  • electrolyte and acid-base imbalance
  • pulmonary edema
  • allergy to Acetazolamide
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
240 participants (actual)

Study arms

  • Active comparator
    1

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

    Drug: sodium bicarbonate

  • Active comparator
    2

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

    Drug: Acetazolamide

  • Active comparator
    3

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

    Drug: normal salin

Interventions

  • Drugsodium bicarbonate

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

    Also known as: no other name

  • DrugAcetazolamide

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

    Also known as: Diamox

  • Drugnormal salin

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

    Also known as: no other name

06

What researchers measure

Primary outcomes

  1. Increased base line creatinine at least 25%

    Time frame: 24 hr later

07

Study locations

1 site
  • Fars Heart Foundation , Kowsar hospital
    Shiraz, Iran, Islamic Republic of
08

References and documents

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. doi: 10.1007/s00246-005-1132-z. PubMed 16391986 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00634491
Lead sponsor
Shiraz University of Medical Sciences
Collaborators
Fars Heart Foundation
First posted
Mar 13, 2008
Start date
Sep 2007
Primary completion
Feb 2008
Completion
Feb 2008
Last update
Mar 13, 2008

Study contacts

Maryam Pakfetrat, MD
study chair · Shiraz nephro-urology research center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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