Critical CareALGO-REANCT04817696
Epidemiology of Chronic Pain as Part of the Post-intensive Care Syndrome
An observational study of Critical Care and Chronic Pain, run by Nantes University Hospital at 1 site in France.
Trial summary
Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Care, Chronic Pain
- What is being tested?
- Patients without chronic pain symptoms and Patients with chronic pain symptoms
- How many people
- 1,079 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2021to 25 Jan 2022
- 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: All patients admitted in ICU with a length of stay > 48 hours and without major cognitive impairment that could prevent an accurate evaluation of pain
Who may be able to join
- All patients admitted in ICU
- ICU length-of-stay ≥ 48 hours
- No major cognitive impairment that could prevent pain evaluation
Who cannot join
- Patient under 18-year-old
- Patient under guardianship
- Patient unable to communicate or quantify pain with a Verbal Score and ID-Pain score
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study
Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.
Read the detailed description
Post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. These chronic health issues bear tremendous burden for patients and next-of-kin. Among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. In the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. The investigators have addressed these patients to pain care specialists, with successful treatment success. However, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. The incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge.
The aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. The investigators intend to describe the incidence of chronic pain assessed with a Simple Verbal Score ≥ 3, 3 months after the ICU admission. The investigators also intend to describe the incidence of painful symptoms, at ICU discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the ID-Pain scale. The evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. The investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis.
The investigators are performing a nation-wide multicentric study. At this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.
- Conditions
- Critical Care, Chronic Pain
- Being tested
- Patients without chronic pain symptoms, Patients with chronic pain symptoms
- Keywords
- PICS, Post Intensive Care Syndrome, Chronic Pain, Critical Care
- Medical subject headings
- Chronic Pain, postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients without chronic pain symptomsOther
Verbal score < 3 at 3 months
Patients with chronic pain symptomsOther
Verbal score ≥ 3 at 3 months
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission
Chronic pain is defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3.
Measured: 3 months after the ICU admission
Secondary outcomes (13)
Intensity of pain, and risk factors associated with pain at 3 months after ICU admission
The incidence of pain defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3
Measured: ICU discharge (median 7 days)
Type of pain (ie neuropathic)
The Type of pain will be assessed with the score ID-Pain at ICU discharge, and 3 months after discharge. The ID-Pain is a 6-item scores that characterizes pain.The score ranges from 0 to 5. A score of 2-3 is predictive of a probable neuropathic pain and a score of 4-5 is highly associated with a neuropathic pain. Pain assessment tools require an auto-evaluation, performed by the patient
Measured: ICU discharge (median 7 days) and at 3 months after admission
Pain management and risk factors in the ICU (Use of Remifentanyl)
Binary information (yes/no)
Measured: Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)
Binary information (yes/no)
Measured: Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)
Binary information (yes/no).
Measured: Median 7 days
Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))
Binary information (yes/no).
Measured: Median 7 days
Pain management and risk factors in the ICU (Use of locoregional anesthesia)
Binary information (yes/no).
Measured: Median 7 days
Pain management and risk factors in the ICU (Type surgery and invasive procedures during ICU: Neurosurgery, orthopedic surgery spine surgery, abdominal surgery, thoracic surgery, thoracic drain)
Binary information (yes/no)
Measured: Median 7 days
Pain management and risk factors in the ICU
- These outcomes and measures will be analyzed separately in the regression multivariable models of chronic pain and neuropathic pain.
Measured: Median 7 days
Demographic data
- Age
- Sex
- SAPS II
- Type of ICU admission
- Chronic Cardiovascular diseases: ischemic cardiomyopathy, hypertention
- Chronic use of pain killers
Measured: Baseline
General ICU data (Length of invasive mechanical ventilation)
Measured as the number of days between succesfull weaning of mechanical ventilation and initiation. Median duration : 7 days
Measured: ICU discharge (median 7 days)
General ICU data
- ARDS. Defined as a PaO2/FiO2 ratio < 300mmHg, according to the Berlin definition (JAMA 2012). Binary information (yes/no). Median duration of monitoring : 7 days
Measured: ICU discharge (median 7 days)
General ICU data ( Use of prone positionning during invasive mechanical ventilation)
Binary information (yes/no). Median duration of monitoring :7 days
Measured: ICU discharge (median 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start25 Apr 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical CareStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- 1,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817696
- Sponsor's protocol ID
- RC21_0020
- Acronym
- ALGO-REA
- Status last verified
- Feb 2022
- First submitted
- 1 Feb 2021
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bourdiol A, Legros V, Vardon-Bounes F, Rimmele T, Abraham P, Hoffmann C, Dahyot-Fizelier C, Jonas M, Bouju P, Cirenei C, Launey Y, Le Gac G, Boubeche S, Lamarche E, Huet O, Bezu L, Darrieussecq J, Szczot M, Delbove A, Schmitt J, Lasocki S, Auchabie J, Petit L, Kuhn-Bougouin E, Asehnoune K, Ingles H, Roquilly A, Cinotti R; ALGO-REA study group; Atlanrea Group; Societe Francaise d'Anesthesie-Reanimation-SFAR Research Network. Prevalence and risk factors of significant persistent pain symptoms after critical care illness: a prospective multicentric study. Crit Care. 2023 May 25;27(1):199. doi: 10.1186/s13054-023-04491-w.
PubMed 37226261
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Chronic Pain as Part of Post-resuscitation Syndrome. Multicenter Prospective Non-interventional Study
- ClinicalTrials.gov ID
- NCT04817696
- Acronym / sponsor ID
- ALGO-REA / RC21_0020
- Conditions
- Critical Care, Chronic Pain
- Keywords
- PICS, Post Intensive Care Syndrome, Chronic Pain, Critical Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,079 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 26 Mar 2021 (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.
Post-intensive care syndrome is an entity of cognitive, physical and mental health disorders occurring and persisting after ICU discharge and responsible of disabilities and decrease of quality of life. Nowadays mental and cognitive health impairments appear to be well known but few data are available about chronic pain after a critical care illness. The aim of the study is to determine the incidence and the risks factors of chronic pain after ICU.
Detailed description
Post-intensive care syndrome is receiving growing interest because of the chronic health issues secondary to a critical care admission: neurocognitive impairment, motor sequelae, mood disturbances. These chronic health issues bear tremendous burden for patients and next-of-kin. Among these chronic health issues, chronic pain symptoms could have major consequences on the patient's quality of life. In the local single-center follow-up experience, 6 months after a patient's admission in the critical care unit, around 20% of patients displayed chronic pain symptoms. The investigators have addressed these patients to pain care specialists, with successful treatment success. However, the evaluation of pain symptoms remains simplistic; moreover, the incidence of chronic pain symptoms in patients after critical care unit admission, receives little attention in the literature although these symptoms may literally blunt out all other health issues. The incidence and type of chronic pain symptoms has been poorly described, to the best of knowledge.
The aim of this study is to perform a multi-center nationwide epidemiologic study of chronic pain symptoms after a critical care unit admission. The investigators intend to describe the incidence of chronic pain assessed with a Simple Verbal Score ≥ 3, 3 months after the ICU admission. The investigators also intend to describe the incidence of painful symptoms, at ICU discharge as well as the type of pain symptoms (ie neuropathic pain) at discharge and at 3 months using the ID-Pain scale. The evaluation at 3 months will be performed during a physical follow-up or self-assessed by the patient. The investigators intend to explore the risk factors associated with chronic pain, as an exploratory analysis.
The investigators are performing a nation-wide multicentric study. At this point 24 centers are participating to this study and the investigators expect to include 700 patients with a 3 months follow-up.
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
- All patients admitted in ICU with a length of stay > 48 hours and without major cognitive impairment that could prevent an accurate evaluation of pain
Key inclusion criteria (3 listed)
- All patients admitted in ICU
- ICU length-of-stay ≥ 48 hours
- No major cognitive impairment that could prevent pain evaluation
Key exclusion criteria (4 listed)
- Patient under 18-year-old
- Patient under guardianship
- Patient unable to communicate or quantify pain with a Verbal Score and ID-Pain score
- Refusal to participate
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 |
|---|---|---|
| Patients without chronic pain symptomsVerbal score < 3 at 3 months | Other | – |
| Patients with chronic pain symptomsVerbal score ≥ 3 at 3 months | Other | – |
Primary outcome
Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission
Time frame: 3 months after the ICU admission
Chronic pain is defined as a Simple Verbal Scale (ranging from 0 - no symptoms- to 10 - worst symptoms imaginable-) ≥ 3.
13 secondary outcomes
Intensity of pain, and risk factors associated with pain at 3 months after ICU admission
Time frame: ICU discharge (median 7 days)
Type of pain (ie neuropathic)
Time frame: ICU discharge (median 7 days) and at 3 months after admission
Pain management and risk factors in the ICU (Use of Remifentanyl)
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Morphine)
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of continuous intra-venous Ketamine)
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of anti-hyperalgesia medication (ie : anti-epileptique drugs, gabapentine, tricyclic anti-depressive drugs))
Time frame: Median 7 days
Pain management and risk factors in the ICU (Use of locoregional anesthesia)
Time frame: Median 7 days
Pain management and risk factors in the ICU (Type surgery and invasive procedures during ICU: Neurosurgery, orthopedic surgery spine surgery, abdominal surgery, thoracic surgery, thoracic drain)
Time frame: Median 7 days
Pain management and risk factors in the ICU
Time frame: Median 7 days
Demographic data
Time frame: Baseline
General ICU data (Length of invasive mechanical ventilation)
Time frame: ICU discharge (median 7 days)
General ICU data
Time frame: ICU discharge (median 7 days)
General ICU data ( Use of prone positionning during invasive mechanical ventilation)
Time frame: ICU discharge (median 7 days)
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 18 Feb 2022.
- Derived from this study: PubMed 37226261Bourdiol A, Legros V, Vardon-Bounes F, Rimmele T, Abraham P, Hoffmann C, Dahyot-Fizelier C, Jonas M, Bouju P, Cirenei C, Launey Y, Le Gac G, Boubeche S, Lamarche E, Huet O, Bezu L, Darrieussecq J, Szczot M, Delbove A, Schmitt J, Lasocki S, Auchabie J, Petit L, Kuhn-Bougouin E, Asehnoune K, Ingles H, Roquilly A, Cinotti R; ALGO-REA study group; Atlanrea Group; Societe Francaise d'Anesthesie-Reanimation-SFAR Research Network. Prevalence and risk factors of significant persistent pain symptoms after critical care illness: a prospective multicentric study. Crit Care. 2023 May 25;27(1):199. doi: 10.1186/s13054-023-04491-w.
- 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 Critical Care and Chronic Pain, run by Nantes University Hospital 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 3 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 18 Feb 2022. 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?
Presence of pain (Simple Verbal Scale ≥3) persisting at 3 months after ICU admission (time frame: 3 months after the ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04817696, which also lists 1 linked publication.
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 18 Feb 2022.