Validation of PINI Score in ICU

June 24, 2016 updated by: University Hospital, Clermont-Ferrand
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed 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)

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • Recruiting
        • Chu Clermont-Ferrand
        • Principal Investigator:
          • Sébastien PERBET

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

  • Both patient in ICU

Exclusion Criteria:

  • minor patient
  • No possibility to calculate PINI score
  • Pregnant woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PINI Score
Time Frame: at day 1
at day 1
Biomarkers related to PINI
Time Frame: at day 1
at day 1
Mortality at 28 days
Time Frame: after admission
after admission

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: at day 1
at day 1
Duration of ventilation
Time Frame: at day 1
at day 1
Duration of antibiotherapy
Time Frame: at day 1
at day 1
Duration of renal replacement therapy
Time Frame: at day 1
at day 1
Type of nutrition (enteral/parenteral)
Time Frame: at day 1
at day 1
Calorie content per day
Time Frame: at day 1
at day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

April 14, 2016

First Posted (Estimate)

April 19, 2016

Study Record Updates

Last Update Posted (Estimate)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHU-0258

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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