HypophosphatemiaNCT03740802
Hypophosphatemia as a Predictor in Surgical Resuscitation Sepsis
An observational study of Hypophosphatemia and Infection, run by University Hospital, Brest at 1 site in France.
Trial summary
Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypophosphatemia, Infection
- How many people
- 264 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jan 2018to 9 Apr 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients admitted to 15-bed surgical ICU between January 1, 2015 and June 31, 2015 were screened for inclusion.
Who may be able to join
- Adults
Who cannot join
- Less than 18 years old
- Infected at admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.
Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.
- Conditions
- Hypophosphatemia, Infection
- Medical subject headings
- Hypophosphatemia, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with sepsis within 28 days after ICU admission
Sepsis was defined according to the criteria of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
Measured: 28 days since the ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start26 Jan 2018
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypophosphatemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Retrospective
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740802
- Sponsor's protocol ID
- PORPOISE2-REA (29BRC18.0022)
- Status last verified
- Jan 2018
- First submitted
- 25 Apr 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Hypophosphatemia as a Predictor of Sepsis in Surgical Resuscitation Units.
- ClinicalTrials.gov ID
- NCT03740802
- Acronym / sponsor ID
- PORPOISE2-REA (29BRC18.0022)
- Conditions
- Hypophosphatemia, Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 14 Nov 2018 (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.
Retrospective study in the surgical intensive care unit of the Brest Teaching Hospital (France) during a 6-months period (January 2015 -May 2015) to study the independent association between hypophosphatemia and 28-day infection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted to 15-bed surgical ICU between January 1, 2015 and June 31, 2015 were screened for inclusion.
Key inclusion criteria (1 listed)
- Adults
Key exclusion criteria (2 listed)
- Less than 18 years old
- Infected at admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with sepsis within 28 days after ICU admission
Time frame: 28 days since the ICU admission
Sepsis was defined according to the criteria of the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).
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 27 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypophosphatemia and Infection, run by University Hospital, Brest at 1 site in France.
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 1 inclusion and 2 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 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Number of patients with sepsis within 28 days after ICU admission (time frame: 28 days since the ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Nov 2018; AzTrials last refreshed its copy on 6 Nov 2026.