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NCT01219270 Clinical Trial

Radiocontrast Media Induced Hyponatremia

Percutaneous Coronary Intervention Clinical Trial

Official title:
Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01219270
Other study ID # Hyponatremia-GUGH
Secondary ID
Status Recruiting
Phase N/A
First received October 12, 2010
Last updated October 13, 2010
Start date October 2010
Est. completion date June 2011

Study information
Verified date October 2010
Source Gachon University Gil Medical Center
Contact n/a
Is FDA regulated No
Health authority South Korea: Institutional Review Board
Study type Observational

Clinical Trial Summary

Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date June 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Gachon University Gil Hospital Incheon

Sponsors (1)
Lead Sponsor Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Aronson D, Dragu RE, Nakhoul F, Hir J, Miller A, Boulos M, Zinder O, Green J, Mittleman MA, Markiewicz W. Hyponatremia as a complication of cardiac catheterization: a prospective study. Am J Kidney Dis. 2002 Nov;40(5):940-6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of contrast media induced translocational hyponatremia The will investigator evaluate how often translocational hyponatremia may develop after percutaneous coronary intervention. 01/10/2010-28/02/2011 Yes
Secondary Renal function is affected by the incidence of translocational hyponatremia. Reduced renal function and urine output contribute the development of contrast media induced translocational hyponatremia. 01/10/2010-28/02/2011 Yes
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