NCT02742571

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

2 months

First QC Date

March 3, 2016

Last Update Submit

June 24, 2016

Conditions

ICU Patients

Keywords

Biological evaluation of denutritionDenutritionPINI score

Outcome Measures

Primary Outcomes (3)

  • PINI Score

    at day 1

  • Biomarkers related to PINI

    at day 1

  • Mortality at 28 days

    after admission

Secondary Outcomes (6)

  • Length of stay

    at day 1

  • Duration of ventilation

    at day 1

  • Duration of antibiotherapy

    at day 1

  • Duration of renal replacement therapy

    at day 1

  • Type of nutrition (enteral/parenteral)

    at day 1

  • +1 more secondary outcomes

Interventions

non applicableOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients

You may qualify if:

  • Both patient in ICU

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2016

First Posted

April 19, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

FR(1)