- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03405051
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit (HYPIC)
February 1, 2019 updated by: Centre Hospitalier Régional Metz-Thionville
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit: Morbidity-mortality Impact
Hypokalemia is very common in heart failure patients.
Deleterious effects have been report on the cardiovascular system.
Most of the clinical data concerning this ionic trouble are based on post-hoc study and some findings seemed disjointed.
Study Overview
Status
Completed
Conditions
Detailed Description
This study tried to describe hypokalemia impact during hospital stay in hospitalized patients with heart failure and particularly on mortality and re-hospitalization.
Study Type
Observational
Enrollment (Actual)
250
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Metz, France, 57085
- CHR Metz-Thionville
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients with congestive heart failure admitted to the Heart Failure Unit in the Mercy hospital (CHR Metz-Thionville).
Description
Inclusion Criteria:
- Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville
- Patient with congestive heart failure
Exclusion Criteria:
- None
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of death and re-hospitalization
Time Frame: Month 3
|
The number of death for any reason and re-hospitalization for congestive heart failure
|
Month 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Death
Time Frame: Month 3
|
Percentage of death for any reason
|
Month 3
|
Re-hospitalization
Time Frame: Month 3
|
Percentage of re-hospitalization for congestive heart failure
|
Month 3
|
Length of stay
Time Frame: Month 3
|
Days spent at the hospital
|
Month 3
|
Incidence of hypokalemia
Time Frame: Month 3
|
Percentage of incidence during the stay of hypokalemia
|
Month 3
|
Prevalence of hypokalemia
Time Frame: Month 3
|
Percentage of initial prevalence during the stay of hypokalemia
|
Month 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 15, 2017
Primary Completion (Actual)
November 15, 2018
Study Completion (Actual)
February 1, 2019
Study Registration Dates
First Submitted
January 12, 2018
First Submitted That Met QC Criteria
January 12, 2018
First Posted (Actual)
January 19, 2018
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017-03Obs-CHRMT
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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