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
Recruitment status was Recruiting
Sponsor:
Gachon University Gil Medical Center
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
| Tracking Information | |||||
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| First Received Date ICMJE | October 12, 2010 | ||||
| Last Updated Date | October 13, 2010 | ||||
| Start Date ICMJE | October 2010 | ||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Incidence of contrast media induced translocational hyponatremia [ Time Frame: 01/10/2010~28/02/2011 ] [ Designated as safety issue: Yes ] The investigators make sure to occur translocational hyponatremia after percutaneous coronary intervention. |
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| Change History | Complete list of historical versions of study NCT01219270 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE |
Renal function is affected 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. |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Radiocontrast Media Induced Hyponatremia | ||||
| Official Title ICMJE | Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study | ||||
| Brief Summary | Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients who receive contrast media during percutaneous coronary intervention |
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| Condition ICMJE | Percutaneous Coronary Intervention | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | June 2011 | ||||
| Estimated Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Not Provided | ||||
| Location Countries ICMJE | Korea, Republic of | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01219270 | ||||
| Other Study ID Numbers ICMJE | Hyponatremia-GUGH | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Gachon University Gil Medical Center IRB, Gachon University Gil Medical Center | ||||
| Study Sponsor ICMJE | Gachon University Gil Medical Center | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Gachon University Gil Medical Center | ||||
| Verification Date | October 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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