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

September 23, 2024 updated by: University Hospital, Toulouse

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

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

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

97

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

      • Toulouse, France
        • University Hospital of Toulouse

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

Sampling Method

Probability Sample

Study Population

population of patients surviving a stay in polyvalent resuscitation

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence at 3 months of PICS
Time Frame: 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.
month 3

Collaborators and Investigators

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

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 (Actual)

October 10, 2022

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

September 6, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/22/0215
  • 2022-A01371-42 (Other Identifier: ID-RCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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