- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04201899
HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey (HYPO-P-ICU)
January 31, 2021 updated by: Mette M Berger, Centre Hospitalier Universitaire Vaudois
Hypophosphatemia in the ICU - A One-day Point Prevalence Survey
The point prevalence survey aims at defining the until now unknown real prevalence of hypophosphatemia (defined as blood phosphate value < 0.8 mmol/l) in international critical care settings
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The survey will be conducted on one single day in each centre (D-day), within a week defined by the project coordinator (International PI). On D-Day, the local investigators will be asked
- to complete questions aiming at describing their ICU (number of beds, number of patients present on D-Day, type medical/surgical/other, local phosphate reference value, presence of an hypophosphatemia treatment protocol in the ICU and route of phosphate delivery in case of hypophosphatemia)
- to indicate how many patients had a blood phosphate <0.08 mmol/l, for each patient with hypophosphatemia, to record the exact lowest value on D-Day, and to record age, number of days in ICU on D-Day, presence (or not) of artificial nutrition and continuous renal replacement therapy, if any phosphate administration is ongoing Data will be recorded in and electronic Case Report Form (e-CRF) in REDCap, and analysed with descriptive statistics No outcome data will be recorded (pure point-prevalence) There is no intervention
Study Type
Observational
Enrollment (Actual)
890
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
-
-
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Tartu, Estonia, 50407
- Tartu University Hospital
-
-
-
-
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Nice, France, 06000
- Hopital Pasteur 2
-
-
-
-
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Nyon, Switzerland, 1260
- Hôpital de Nyon
-
-
VD
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Lausanne, VD, Switzerland, 1011
- Lausanne University Hospital
-
-
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
Critically ill patients: adults and children
Description
Inclusion Criteria: blood phosphate value < 0.8 mmol -
Exclusion Criteria: Blood phosphate value >0.8 mmol/l
-
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 |
---|---|---|
Prevalence of hypophosphatemia
Time Frame: 1 day
|
Blood value < 0.8 mmol/l
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Mette M BERGER, MD PhD, Lausanne University Hospital, Lausanne, Switzerland
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
March 9, 2020
Primary Completion (Actual)
July 31, 2020
Study Completion (Actual)
July 31, 2020
Study Registration Dates
First Submitted
December 14, 2019
First Submitted That Met QC Criteria
December 16, 2019
First Posted (Actual)
December 17, 2019
Study Record Updates
Last Update Posted (Actual)
February 2, 2021
Last Update Submitted That Met QC Criteria
January 31, 2021
Last Verified
January 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CER2019-02343
- 2019-021-406 (Other Identifier: Erasme University, Brussels, Belgium)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Data will be collected in central REDCap database.
No individual patient data will be made available
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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