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Completed

NCT Number: NCT05534828

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Toulouse

Toulouse, France

About this study

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

  • The presence of a CHIP in his patient
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

A consultation

Diagnostic Test

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

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study 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

Acronym: PICS3

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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