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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00634491
Other study ID # 2438
Secondary ID
Status Completed
Phase Phase 2
First received February 14, 2008
Last updated March 4, 2008
Start date September 2007
Est. completion date February 2008

Study information

Verified date March 2008
Source Shiraz University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 240
Est. completion date February 2008
Est. primary completion date February 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
sodium bicarbonate
150 meq/l Sodium bicarbonate 3cc/kg/hr before and 1cc/kg/hr after angiography
Acetazolamide
Acetazolamide 250 mg+ 1 cc/kg/hr normal salin before and after angiography
normal salin
1 cc/kg/hr 6 hour before and after angiography

Locations

Country Name City State
Iran, Islamic Republic of Fars Heart Foundation , Kowsar hospital Shiraz

Sponsors (2)

Lead Sponsor Collaborator
Shiraz University of Medical Sciences Fars Heart Foundation

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Increased base line creatinine at least 25% 24 hr later No
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Active, not recruiting NCT01402232 - REduction of rIsk for Contrast Induced Nephropathy
Recruiting NCT02113540 - Assessment of the Effect of Atorvastatin on Prevention of CIN in Patients Undergoing Coronary Angiography Phase 3
Active, not recruiting NCT01456013 - Evaluation of RenalGuard® System to Reduce the Incidence of Contrast Induced Nephropathy in At-Risk Patients Phase 3
Recruiting NCT01399203 - Contrast Medium Volume and Contrast-induced Nephropathy After Percutaneous Coronary Intervention N/A

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