PICS3: Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS)

Sponsor
University Hospital, Toulouse (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05534828
Collaborator
(none)
400
1
15
26.6

Study Details

Study Description

Brief Summary

Monocentric, observational, descriptive RIPH3 study with prospective data collection.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: A consultation

Detailed Description

A consultation in the form of a teleconsultation with video conference is proposed to all adult patients who have stayed more than 24 hours in the Rangueil intensive care unit.

This consultation is scheduled and will take place approximately three months after the end of the stay in the intensive care unit.

During this consultation, signs will be sought through questioning to detect or even diagnose the presence of a PICS.

We will also look for elements that will allow us to characterize people with CHIP.

If a PICS was detected during the consultation, the summary letter sent to the attending physician informs him/her of

  1. The presence of a CHIP in his patient

  2. The nature of this CHIP (CHIP with a purely psychological component, CHIP with a psychological and physical component, etc.) In this same summary letter, the attending physician will be offered a list of specialists practicing at the CHU who are likely to take charge of the patient's CHIP.

Study Design

Study Type:
Observational
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS) at 3 Months After a Stay in the Rangueil Multipurpose Resuscitation Unit of the Toulouse University Hospital
Anticipated Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2024
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Incidence at 3 months of PICS [month 3]

    Incidence at 3 months of PICS as defined below: A PICS is defined as ''present'' at the 3-month visit if the patient has one or more of the following: Impaired quality of life as defined by a 5D5L EQ score greater than or equal to 3 on at least 1 dimension of the questionnaire. Anxiety symptoms defined by a HADS anxiety score greater than or equal to 11. Depressive symptoms defined by a HADS depression score greater than or equal to 11. Symptoms of post-traumatic stress defined by a PCL 5 score greater than or equal to 33. Symptoms of undernutrition defined by an NRS score greater than or equal to 3. Pain symptoms defined by a DN4 score greater than or equal to 4 and/or an EVS score greater than or equal to 4.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • adult patient

  • hospitalized in the intensive care unit of Rangueil of the TOULOUSE University Hospital

  • length of stay in intensive care equal or superior to 24 hours

  • affiliated to a social security system

  • having expressed no objection to participate in the study

Exclusion Criteria:
  • minor patient

  • no consent to the study

  • patient not capable of expressing his "non opposition" to the study

  • patient under guardianship, curatorship or safeguard of justice

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Toulouse Toulouse France

Sponsors and Collaborators

  • University Hospital, Toulouse

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT05534828
Other Study ID Numbers:
  • RC31/22/0215
  • 2022-A01371-42
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 10, 2022