Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU (PORPOISE-REA)
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ClinicalTrials.gov Identifier: NCT03529058 |
Recruitment Status :
Completed
First Posted : May 18, 2018
Last Update Posted : May 18, 2018
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Sponsor:
University Hospital, Brest
Information provided by (Responsible Party):
University Hospital, Brest
Tracking Information | |||||
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First Submitted Date | April 5, 2018 | ||||
First Posted Date | May 18, 2018 | ||||
Last Update Posted Date | May 18, 2018 | ||||
Actual Study Start Date | November 26, 2017 | ||||
Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
90-day mortality [ Time Frame: 90 days since the first blood stream infection in ICU ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | No Changes Posted | ||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU | ||||
Official Title | Evaluation of Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU | ||||
Brief Summary | Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France) during a 18-months period (June 2014 -December 2015) to study the independent association between hypophosphatemia and 90-day mortality. | ||||
Detailed Description | Not Provided | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | All patients admitted to 21-bed medical ICU, 15-bed surgical ICU and 8-bed cardiothoracic ICU between June 1, 2014 and December 31, 2015 were screened for inclusion. | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts | Not Provided | ||||
Publications * | Padelli M, Aubron C, Huet O, Héry-Arnaud G, Vermeersch V, Hoffmann C, Bettacchioli É, Maguet H, Carré JL, Leven C. Is hypophosphataemia an independent predictor of mortality in critically ill patients with bloodstream infection? A multicenter retrospective cohort study. Aust Crit Care. 2021 Jan;34(1):47-54. doi: 10.1016/j.aucc.2020.05.001. Epub 2020 Jul 27. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
193 | ||||
Original Actual Enrollment | Same as current | ||||
Actual Study Completion Date | March 31, 2018 | ||||
Actual Primary Completion Date | March 31, 2018 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03529058 | ||||
Other Study ID Numbers | PORPOISE-REA ( 29BRC17.0180) | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||
Responsible Party | University Hospital, Brest | ||||
Study Sponsor | University Hospital, Brest | ||||
Collaborators | Not Provided | ||||
Investigators | Not Provided | ||||
PRS Account | University Hospital, Brest | ||||
Verification Date | November 2017 |