HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey (NCT04201899)

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Study 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

Read the 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

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Conditions studied

Critically Ill

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Keywords

Phosphate

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Who can participate

Ages eligible: Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Non-probability sample

Study population

Critically ill patients: adults and children

Eligibility criteria

Inclusion Criteria: blood phosphate value \< 0.8 mmol -

Exclusion Criteria: Blood phosphate value >0.8 mmol/l

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Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 890 participants (actual)
Target follow-up: 1 Day
Patient registry: Yes

Interventions

Dietary supplementNo intervention - pure observation
Phosphate administration (yes or no)

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What researchers measure

Primary outcomes

Prevalence of hypophosphatemia
Blood value \< 0.8 mmol/l
Time frame: 1 day

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Study locations

4 sites

Tartu University Hospital
Tartu, 50407, Estonia
Hôpital Pasteur 2
Nice, 06000, France
Lausanne University Hospital
Lausanne, VD 1011, Switzerland
Hôpital de Nyon
Nyon, 1260, Switzerland

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References and documents

Publications

Berger MM, Appelberg O, Reintam-Blaser A, Ichai C, Joannes-Boyau O, Casaer M, Schaller SJ, Gunst J, Starkopf J; ESICM-MEN section. Prevalence of hypophosphatemia in the ICU - Results of an international one-day point prevalence survey. Clin Nutr. 2021 May;40(5):3615-3621. doi: 10.1016/j.clnu.2020.12.017. Epub 2020 Dec 29. PubMed 33454128 ↗

Individual participant data

Plan to share: No — Data will be collected in central REDCap database. No individual patient data will be made available

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Registry details

Key details

Study ID: NCT04201899
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Collaborators: European Society of Intensive Care Medicine
Responsible party: Mette M Berger (Principal Investigator, Centre Hospitalier Universitaire Vaudois) — Principal investigator
First posted: Dec 17, 2019
Start date: Mar 9, 2020
Primary completion: Jul 31, 2020
Completion: Jul 31, 2020
Last update: Feb 2, 2021

Study contacts

Mette M BERGER, MD PhD

principal investigator · Lausanne University Hospital, Lausanne, Switzerland

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey