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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02742571
Other study ID # CHU-0258
Secondary ID
Status Recruiting
Phase N/A
First received March 3, 2016
Last updated June 24, 2016
Start date April 2016
Est. completion date July 2016

Study information

Verified date June 2016
Source University Hospital, Clermont-Ferrand
Contact Patrick LACARIN
Phone 04 73 75 11 95
Email placarin@chu-clermontferrand.fr
Is FDA regulated No
Health authority France: Commission nationale de l'informatique et des libertés
Study type Observational

Clinical Trial Summary

Prospective, observational clinical monocentric study in ICU; Relationship between Pronostic Inflammatory and Nutritional Index (PINI) (and biomarkers related to PINI) and mortality, morbidity and nutrition in ICU


Description:

Main objective: to evaluate the relationship between PINI score and biomarker related to PINI, and 28 days mortality in ICU

Secondary objectives:

- to evaluate the relationship between PINI score (and biomarkers related to PINI) and morbidity in ICU : SOFA score, duration of ventilation, duration of antibiotherapy, duration of extra renal epuration, length of stay

- to evaluate the relationship between PINI score (and biomarkers related to PINI) and nutrition in ICU (type of nutrition, calorie content)


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date July 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Both patient in ICU

Exclusion Criteria:

- minor patient

- No possibility to calculate PINI score

- Pregnant woman

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Other:
non applicable


Locations

Country Name City State
France CHU Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary PINI Score at day 1 No
Primary Biomarkers related to PINI at day 1 No
Primary Mortality at 28 days after admission No
Secondary Length of stay at day 1 No
Secondary Duration of ventilation at day 1 No
Secondary Duration of antibiotherapy at day 1 No
Secondary Duration of renal replacement therapy at day 1 No
Secondary Type of nutrition (enteral/parenteral) at day 1 No
Secondary Calorie content per day at day 1 No
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