- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01219270
Radiocontrast Media Induced Hyponatremia
October 13, 2010 updated by: Gachon University Gil Medical Center
Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study
Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.
Study Overview
Status
Unknown
Conditions
Detailed Description
Radiocontrast media after percutaneous coronary interventioncan lead to increased osmolaliry of plasma, which results in translocational hyponatremia.
The investigator will exam the incidence of hyponatremia after percutaneous coronary intervention, and will evaluate the underlying mechanism related to hyponatremia including translocational hyponatremia, or osmotic natriuresis.
Study Type
Observational
Enrollment (Anticipated)
100
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
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-
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Incheon, Korea, Republic of
- Recruiting
- Gachon University Gil Hospital
-
Contact:
- Wookyung Chung, MD, PhD
- Phone Number: +82-32-460-3431
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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 to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients who receive contrast media during percutaneous coronary intervention
Description
Inclusion Criteria:
- Patients who receive contrast media during percutaneous coronary intervention
Exclusion Criteria:
- Patients who have sensitivity to contrast media.
- Liver cirrhosis
- Hypothyroidism
- SIADH
- Patients who receive IVIG or mannitol.
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
Cohorts and Interventions
Group / Cohort |
|---|
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GFR >= 60
MDRD eGFR 60 or more
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GFR <60
Under MDRD eGFR 60
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of contrast media induced translocational hyponatremia
Time Frame: 01/10/2010-28/02/2011
|
The will investigator evaluate how often translocational hyponatremia may develop after percutaneous coronary intervention.
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01/10/2010-28/02/2011
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Renal function is affected by the incidence of translocational hyponatremia.
Time Frame: 01/10/2010-28/02/2011
|
Reduced renal function and urine output contribute the development of contrast media induced translocational hyponatremia.
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01/10/2010-28/02/2011
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sejoong Kim, MD, PhD, Gachon University Gil Medical Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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
October 1, 2010
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
June 1, 2011
Study Registration Dates
First Submitted
October 12, 2010
First Submitted That Met QC Criteria
October 12, 2010
First Posted (Estimate)
October 13, 2010
Study Record Updates
Last Update Posted (Estimate)
October 14, 2010
Last Update Submitted That Met QC Criteria
October 13, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Hyponatremia-GUGH
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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