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HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey (HYPO-P-ICU)

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ClinicalTrials.gov Identifier: NCT04201899
Recruitment Status : Completed
First Posted : December 17, 2019
Last Update Posted : February 2, 2021
Sponsor:
Collaborator:
European Society of Intensive Care Medicine
Information provided by (Responsible Party):
Mette M Berger, Centre Hospitalier Universitaire Vaudois

Brief Summary:
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

Condition or disease Intervention/treatment
Critically Ill Dietary Supplement: No intervention - pure observation

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

  1. 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)
  2. 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

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Study Type : Observational [Patient Registry]
Actual Enrollment : 890 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Hypophosphatemia in the ICU - A One-day Point Prevalence Survey
Actual Study Start Date : March 9, 2020
Actual Primary Completion Date : July 31, 2020
Actual Study Completion Date : July 31, 2020

Intervention Details:
  • Dietary Supplement: No intervention - pure observation
    Phosphate administration (yes or no)


Primary Outcome Measures :
  1. Prevalence of hypophosphatemia [ Time Frame: 1 day ]
    Blood value < 0.8 mmol/l



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Critically ill patients: adults and children
Criteria

Inclusion Criteria: blood phosphate value < 0.8 mmol -

Exclusion Criteria: Blood phosphate value >0.8 mmol/l

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04201899


Locations
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Estonia
Tartu University Hospital
Tartu, Estonia, 50407
France
Hôpital Pasteur 2
Nice, France, 06000
Switzerland
Lausanne University Hospital
Lausanne, VD, Switzerland, 1011
Hôpital de Nyon
Nyon, Switzerland, 1260
Sponsors and Collaborators
Centre Hospitalier Universitaire Vaudois
European Society of Intensive Care Medicine
Investigators
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Principal Investigator: Mette M BERGER, MD PhD Lausanne University Hospital, Lausanne, Switzerland
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mette M Berger, Principal Investigator, Centre Hospitalier Universitaire Vaudois
ClinicalTrials.gov Identifier: NCT04201899    
Other Study ID Numbers: CER2019-02343
2019-021-406 ( Other Identifier: Erasme University, Brussels, Belgium )
First Posted: December 17, 2019    Key Record Dates
Last Update Posted: February 2, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be collected in central REDCap database. No individual patient data will be made available

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mette M Berger, Centre Hospitalier Universitaire Vaudois:
Phosphate
Additional relevant MeSH terms:
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Hypophosphatemia
Critical Illness
Disease Attributes
Pathologic Processes
Phosphorus Metabolism Disorders
Metabolic Diseases