Critically IllHYPO-P-ICUNCT04201899
HYPOPhosphatemia in the Intensive Care: A One-day Point Prevalence Survey
An observational study of Critically Ill, run by Centre Hospitalier Universitaire Vaudois at 4 sites in 3 countries.
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critically Ill
- How many people
- 890 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 9 Mar 2020to 31 Jul 2020
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Critically ill patients: adults and children
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Switzerland2 sites
Lausanne University Hospital
Lausanne, Canton of Vaud, 1011
Hôpital de Nyon
Nyon, 1260
About this study
Official title: 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
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
- Conditions
- Critically Ill
- Being tested
- No intervention - pure observation
- Keywords
- Phosphate
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention - pure observationDietary supplement
Phosphate administration (yes or no)
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hypophosphatemia
Blood value < 0.8 mmol/l
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start9 Mar 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 890 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Responsible party
- Principal investigator, Mette M Berger, Centre Hospitalier Universitaire Vaudois
- Investigators
- Mette M BERGER, MD PhD, Principal investigator, Lausanne University Hospital, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201899
- Sponsor's protocol ID
- CER2019-02343
- Other IDs
- 2019-021-406
- Acronym
- HYPO-P-ICU
- Status last verified
- Jan 2021
- First submitted
- 14 Dec 2019
- Last updated
- 2 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected in central REDCap database. No individual patient data will be made available
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypophosphatemia in the ICU - A One-day Point Prevalence Survey
- ClinicalTrials.gov ID
- NCT04201899
- Acronym / sponsor ID
- HYPO-P-ICU / CER2019-02343
- Conditions
- Critically Ill
- Keywords
- Phosphate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 890 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Collaborators
- European Society of Intensive Care Medicine
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 17 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Critically ill patients: adults and children
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention - pure observationPhosphate administration (yes or no) | Dietary supplement | – |
Primary outcome
Prevalence of hypophosphatemia
Time frame: 1 day
Blood value < 0.8 mmol/l
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2021.
- Derived from this study: PubMed 33454128Berger 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.
- Individual participant dataSharing planned: No. Data will be collected in central REDCap database. No individual patient data will be made available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette M BERGER, MD PhD principal investigator
Lausanne University Hospital, Lausanne, Switzerland
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critically Ill, run by Centre Hospitalier Universitaire Vaudois at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland, Estonia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of hypophosphatemia (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04201899, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2021.