Percutaneous Coronary InterventionNCT01219270
Radiocontrast Media Induced Hyponatremia
An observational study of Percutaneous Coronary Intervention, run by Gachon University Gil Medical Center at 1 site in South Korea.
Trial summary
Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Percutaneous Coronary Intervention
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2010to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who receive contrast media during percutaneous coronary intervention
Who may be able to join
- Patients who receive contrast media during percutaneous coronary intervention
Who cannot join
- Patients who have sensitivity to contrast media.
- Liver cirrhosis
- Hypothyroidism
- SIADH
- Patients who receive IVIG or mannitol.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon University Gil Hospital
Incheon
Wookyung Chung, MD, PhD, +82-32-460-3431
About this study
Official title: Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study
Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.
Read the 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.
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Radiocontrast media,, hyponatremia
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GFR >= 60 | MDRD eGFR 60 or more | |
| GFR <60 | Under MDRD eGFR 60 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of contrast media induced translocational hyponatremia
The will investigator evaluate how often translocational hyponatremia may develop after percutaneous coronary intervention.
Measured: 01/10/2010-28/02/2011
Secondary outcomes (1)
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.
Measured: 01/10/2010-28/02/2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionFeb 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Sejoong Kim, MD, PhD, Principal investigator, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01219270
- Sponsor's protocol ID
- Hyponatremia-GUGH
- Status last verified
- Oct 2010
- First submitted
- 12 Oct 2010
- Last updated
- 14 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1053/ajkd.2002.36324.
PubMed 12407638
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiocontrast Media Induced Hyponatremia After Percutaneous Coronary Intervention: Observational Study
- ClinicalTrials.gov ID
- NCT01219270
- Acronym / sponsor ID
- Hyponatremia-GUGH
- Conditions
- Percutaneous Coronary Intervention
- Keywords
- Radiocontrast media,, hyponatremia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 13 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Osmolality of contrast media can be resulted in translocational hyponatremia after percutaneous coronary intervention.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GFR >= 60 | – | –MDRD eGFR 60 or more |
| GFR <60 | – | –Under MDRD eGFR 60 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who receive contrast media during percutaneous coronary intervention
Key inclusion criteria (1 listed)
- Patients who receive contrast media during percutaneous coronary intervention
Key exclusion criteria (5 listed)
- Patients who have sensitivity to contrast media.
- Liver cirrhosis
- Hypothyroidism
- SIADH
- Patients who receive IVIG or mannitol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Renal function is affected by the incidence of translocational hyponatremia.
Time frame: 01/10/2010-28/02/2011
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2010.
- Background: PubMed 12407638Aronson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sejoong Kim, MD, PhD principal investigator
Gachon University Gil Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Percutaneous Coronary Intervention, run by Gachon University Gil Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of contrast media induced translocational hyponatremia (time frame: 01/10/2010-28/02/2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01219270, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2010.