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Radiocontrast Media Induced Hyponatremia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Gachon University Gil Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01219270
First received: October 12, 2010
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  Purpose

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


Condition
Percutaneous Coronary Intervention

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study

Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Incidence of contrast media induced translocational hyponatremia [ Time Frame: 01/10/2010-28/02/2011 ] [ Designated as safety issue: Yes ]
    The will investigator evaluate how often translocational hyponatremia may develop after percutaneous coronary intervention.


Secondary Outcome Measures:
  • Renal function is affected by the incidence of translocational hyponatremia. [ Time Frame: 01/10/2010-28/02/2011 ] [ Designated as safety issue: Yes ]
    Reduced renal function and urine output contribute the development of contrast media induced translocational hyponatremia.


Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
GFR >= 60
MDRD eGFR 60 or more
GFR <60
Under MDRD eGFR 60

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients who receive contrast media during percutaneous coronary intervention

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01219270

Locations
Korea, Republic of
Gachon University Gil Hospital Recruiting
Incheon, Korea, Republic of
Contact: Wookyung Chung, MD, PhD     +82-32-460-3431        
Sponsors and Collaborators
Gachon University Gil Medical Center
Investigators
Principal Investigator: Sejoong Kim, MD, PhD Gachon University Gil Medical Center
  More Information

Publications:

Responsible Party: Gachon University Gil Medical Center IRB, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01219270     History of Changes
Other Study ID Numbers: Hyponatremia-GUGH
Study First Received: October 12, 2010
Last Updated: October 13, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
Radiocontrast media,
hyponatremia

Additional relevant MeSH terms:
Hyponatremia
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013