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

NCT05534828 | Completed

• 2 other identifiers: RC31/22/02152022-A01371-42
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post Intensive Care Syndrome

Outcome Measures

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.

  month 3

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

population of patients surviving a stay in polyvalent resuscitation

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

University Hospital of Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

postintensive care syndrome

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: October 10, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: September 25, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)