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

Post Intensive Care Syndrome Clinical Trial

— PICS3  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05534828
• Other study ID #: RC31/22/0215
• Secondary ID: 2022-A01371-42
• Status: Not yet recruiting
• Start date: October 2022
• Est. completion date: January 2024

Study information

• Verified date: September 2022
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Intensive Care Syndrome
• Syndrome

Intervention

Diagnostic Test:
• A 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

Locations

Country	Name	City	State
France	University Hospital of Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	month 3