Post Intensive Care SyndromePICS3NCT05534828
Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS)
An observational study of Post Intensive Care Syndrome, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Monocentric, observational, descriptive RIPH3 study with prospective data collection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome
- What is being tested?
- A consultation
- How many people
- 97 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: population of patients surviving a stay in polyvalent resuscitation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- 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.
- Conditions
- Post Intensive Care Syndrome
- Being tested
- A consultation
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A consultationDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start10 Oct 2022
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534828
- Sponsor's protocol ID
- RC31/22/0215
- Other IDs
- 2022-A01371-42
- Acronym
- PICS3
- Status last verified
- Sep 2024
- First submitted
- 6 Sep 2022
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05534828
- Acronym / sponsor ID
- PICS3 / RC31/22/0215
- Conditions
- Post Intensive Care Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 10 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Monocentric, observational, descriptive RIPH3 study with prospective data collection.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- population of patients surviving a stay in polyvalent resuscitation
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A consultationA consultation at three months of discharge from the intensive care unit in the population of patients surviving a multivalent intensive care unit stay | Diagnostic test | – |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Syndrome, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence at 3 months of PICS (time frame: month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024; AzTrials last refreshed its copy on 8 Nov 2026.