Validation of PINI Score in ICU

ICU Patients Clinical Trial

Official title:

Validation of PINI Score in ICU

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02742571
• Other study ID #: CHU-0258
• 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

• ICU Patients

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