- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172353
Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy
January 7, 2014 updated by: Vitor Osorio Gomes, Hospital Sao Lucas da PUCRS
Hydration With Sodium Bicarbonate for Prevention of Contrast-Induced Nephropathy: A Multicenter Clinical Trial
The purpose of this study is to determine whether hydration with sodium bicarbonate is superior to hydration with saline to prevent contrast-induced nephropathy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
301
Phase
- Phase 3
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
-
-
RS
-
Porto Alegre, RS, Brazil, 90610-000
- São Lucas Hospital - PUCRS University
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- serum creatinine > 1.1 mg/dL
- glomerular filtration rate (GFR) < 50 mL/min
Exclusion Criteria:
- age < 18 years
- use of radiographic contrast media during the last 21 days
- history of dialysis
- cardiac insufficiency class III-IV
- emergency procedures
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: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: sodium bicarbonate
hydration with sodium bicarbonate
|
hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
|
Active Comparator: saline
hydration with saline 1ml/Kg/h for 6 hours
|
hydration with saline 1ml/Kg/h for 6 hours
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contrast-induced Nephropathy
Time Frame: 48 hours
|
rise in serum creatinine >0,5mg/dl
|
48 hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dialysis During Hospitalization
Time Frame: During hospitalization
|
During hospitalization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
July 1, 2004
Primary Completion (Actual)
January 1, 2008
Study Completion (Actual)
February 1, 2008
Study Registration Dates
First Submitted
July 28, 2010
First Submitted That Met QC Criteria
July 28, 2010
First Posted (Estimate)
July 29, 2010
Study Record Updates
Last Update Posted (Estimate)
February 19, 2014
Last Update Submitted That Met QC Criteria
January 7, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSaoLucas
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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