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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04201899
Other study ID # CER2019-02343
Secondary ID 2019-021-406
Status Completed
Phase
First received
Last updated
Start date March 9, 2020
Est. completion date July 31, 2020

Study information

Verified date January 2021
Source Centre Hospitalier Universitaire Vaudois
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 890
Est. completion date July 31, 2020
Est. primary completion date July 31, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: blood phosphate value < 0.8 mmol - Exclusion Criteria: Blood phosphate value >0.8 mmol/l -

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Estonia Tartu University Hospital Tartu
France Hôpital Pasteur 2 Nice
Switzerland Lausanne University Hospital Lausanne VD
Switzerland Hôpital de Nyon Nyon

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire Vaudois European Society of Intensive Care Medicine

Countries where clinical trial is conducted

Estonia,  France,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Prevalence of hypophosphatemia Blood value < 0.8 mmol/l 1 day
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