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CompletedNCT05534828PICS3Updated Sep 25, 2024

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

An observational study in Post Intensive Care Syndrome, sponsored by University Hospital, Toulouse. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by University Hospital, Toulouse · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
97
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Post Intensive Care Syndrome
03

In context

postintensive care syndrome

49 studies on the registry are indexed under postintensive care syndrome; 26 are open to participants now.

This study's enrollment of 97 is below the median of 200 across 23 observational studies indexed under postintensive care syndrome.

Browse postintensive care syndrome studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 805 studies on the registry; 215 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

population of patients surviving a stay in polyvalent resuscitation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
97 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testA consultation

    A consultation at three months of discharge from the intensive care unit in the population of patients surviving a multivalent intensive care unit stay

06

What researchers measure

Primary outcomes

  1. Incidence at 3 months of PICS

    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.

    Time frame: month 3

07

Study locations

1 site
  • University Hospital of Toulouse
    Toulouse, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05534828
Responsible party
Sponsor
First posted
Sep 10, 2022
Start date
Oct 10, 2022
Primary completion
Jun 30, 2023
Completion
Jun 30, 2023
Last update
Sep 25, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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