Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU (PORPOISE-REA)

• ClinicalTrials.gov Identifier: NCT03529058
• Recruitment Status: Completed
• First Posted: May 18, 2018
• Last Update Posted: May 18, 2018
• Sponsor: University Hospital, Brest
• Information provided by (Responsible Party): University Hospital, Brest

Tracking Information

• 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 (submitted: May 7, 2018): 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
• 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

• Hypophosphatemia
• Infection

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 7, 2018): 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:

• Blood stream infection

Exclusion Criteria:

• Less than 18 years old

Sex/Gender

• Sexes Eligible for Study: All

• 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

Administrative Information

• NCT Number: NCT03529058
• Other Study ID Numbers: PORPOISE-REA ( 29BRC17.0180)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• 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