NCT01219270

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

October 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 14, 2010

Status Verified

October 1, 2010

Enrollment Period

4 months

First QC Date

October 12, 2010

Last Update Submit

October 13, 2010

Conditions

Percutaneous Coronary Intervention

Keywords

Radiocontrast media,hyponatremia

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Renal function is affected by the incidence of translocational hyponatremia.

    01/10/2010-28/02/2011

Study Arms (2)

GFR >= 60

MDRD eGFR 60 or more

GFR <60

Under MDRD eGFR 60

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who receive contrast media during percutaneous coronary intervention

You may qualify if:

  • Patients who receive contrast media during percutaneous coronary intervention

You may not qualify if:

  • Patients who have sensitivity to contrast media.
  • Liver cirrhosis
  • Hypothyroidism
  • SIADH
  • Patients who receive IVIG or mannitol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Hospital

Incheon, South Korea

RECRUITING

Related 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. doi: 10.1053/ajkd.2002.36324.

    PMID: 12407638BACKGROUND

MeSH Terms

Conditions

Hyponatremia

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Sejoong Kim, MD, PhD

    Gachon University Gil Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 12, 2010

First Posted

October 13, 2010

Study Start

October 1, 2010

Primary Completion

February 1, 2011

Study Completion

June 1, 2011

Last Updated

October 14, 2010

Record last verified: 2010-10

Locations

KR(1)