Clinical trial NCT04940208: Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit
Official title: Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit - a Multicenter Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
ICU
Pain, Chronic
Post Intensive Care Unit Syndrome
Neuropathic Pain
Keywords: SARS-COV2
Intensive care unit
critical illness survivors
chronic pain
COVID long
Neuropathic pain
Quantitative Sensory testing
Lead sponsor: Hôpital de la Croix-Rousse
Sponsor class: OTHER
Collaborators: name: Hôpital Raymond Poincaré
name: Bicetre Hospital
First posted: 2021-06-25
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult patients, infected with SARS COV2 and developed severe COVID, requiring hospitalisation to the ICU during the first French wave of COVID 19, with length of stay \> 48 hours, survived and successfully discharged, and approached from 6th month post discharge.

Brief summary: More than six million French were affected by SARS-COV2 epidemic. About 20% of infected peoples were hospitalized, and about 5% were admitted to the intensive care units (ICU) for severe SARS-COV2 acute respiratory distress syndrome (ARDS) management.

A spectrum of neuropsychiatric sequelae, specific for the ICU exposure, was already described, including post-intensive care syndrome and persistent pain.

A growing body of evidence suggests the impact of SARS-COV2 exposure on the occurrence of neurological disorders and chronic pain syndrome development in COVID-19 patients.

Taking together, one can expect a large number of patients discharged from ICU after severe COVID-19 with high prevalence of persistent pain and psychological disorders. To date, no study has evaluated neither the incidence of persistant pains in ICU COVID-19 survivors, nor pain phenotypes.

The knowledge of such data is crucial in order to anticipate the management of such patients by specialized pain team, and to quantify the possible incurred burden of care.

Our study aims to evaluate the incidence of pain, pain localization and severity, associated pain-related psychological disorders, and to perform quantitative sensory testing in severe COVID-19 patients, admitted to the ICU for more than 48 hours and successfully discharged home during the first French pandemic wave.


Eligibility criteria: Inclusion Criteria:

* adults (\>=18 y.o.)
* hospitalized in the ICU for at least 48 hours
* with SARS-Cov2 infection confirmed by Polymerase Chain Reaction (PCR)/serology and/or a suggestive chest Computed Tomography scan
* during the first wave of COVID 19 from March to December 2020 at three investigator sites (2 in Paris and 1 in Lyon)
* discharged alive from the ICU
* at least 6 months after discharge

Exclusion Criteria:

* patient refusal
* inability to communicate or to have in-person appointment
* death in the period from ICU discharge to the first phone call for interview

Primary outcomes:
measure: Incidence of secondary chronic pain
timeFrame: starting 6 month after discharge
Secondary outcomes:
measure: Frequency of different secondary chronic pain classes
timeFrame: starting 6 month after discharge
measure: Pain sensitivity level
timeFrame: starting 6 month after discharge
measure: Pain localization
timeFrame: starting 6 month after discharge
measure: The severity of pain and its impact on functioning
timeFrame: starting 6 month after discharge
measure: Neuropathic pain
timeFrame: starting 6 month after discharge
measure: Spiegel Sleep Quality Questionnaire
timeFrame: starting 6 month after discharge
measure: Posttraumatic Stress Disorder
timeFrame: starting 6 month after discharge
measure: Anxiety and Depression
timeFrame: starting 6 month after discharge
measure: Pain Catastrophizing Level
timeFrame: starting 6 month after discharge
measure: Perceived Stress Level
timeFrame: starting 6 month after discharge
measure: Summation pain threshold
timeFrame: starting 6 month after discharge
measure: Heat pain threshold
timeFrame: starting 6 month after discharge
Other outcomes:
Locations:
city: Garches
country: France
facility: Hôpital Raymond Poincare - AP-HP
state: Hauts-de-Seine
city: Le Kremlin-Bicêtre
country: France
facility: Hôpital Bicêtre AP-HP
city: Lyon
country: France
facility: Hopital de la Croix Rousse - Hospices Civils de Lyon
Study officials:
References:
citation: Carfi A, Bernabei R, Landi F; Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19. JAMA. 2020 Aug 11;324(6):603-605. doi: 10.1001/jama.2020.12603.
citation: Needham EJ, Chou SH, Coles AJ, Menon DK. Neurological Implications of COVID-19 Infections. Neurocrit Care. 2020 Jun;32(3):667-671. doi: 10.1007/s12028-020-00978-4.
citation: Asadi-Pooya AA, Simani L. Central nervous system manifestations of COVID-19: A systematic review. J Neurol Sci. 2020 Jun 15;413:116832. doi: 10.1016/j.jns.2020.116832. Epub 2020 Apr 11.
citation: Lee AM, Wong JG, McAlonan GM, Cheung V, Cheung C, Sham PC, Chu CM, Wong PC, Tsang KW, Chua SE. Stress and psychological distress among SARS survivors 1 year after the outbreak. Can J Psychiatry. 2007 Apr;52(4):233-40. doi: 10.1177/070674370705200405.