Chronic Pain in COVID-19 Patients Discharged From Intensive Care Unit

NCT ID: NCT04940208

Last Updated: 2022-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

143 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-11

Study Completion Date

2022-02-01

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19 Pandemic ICU Pain, Chronic Post Intensive Care Unit Syndrome Neuropathic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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post COVID-19 ICU survivors

Patients hospitalized to the ICU in the context of severe COVID-19 and discharged alive during the first French COVID-19 pandemic wave

Pain and neuropsychological questionnaires

Intervention Type OTHER

Patient-reported outcomes, listed in the Secondary Outcome Measure Section

Quantitative Sensory testing

Intervention Type DIAGNOSTIC_TEST

Summation pain threshold test and Heat pain threshold skin test

Interventions

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Pain and neuropsychological questionnaires

Patient-reported outcomes, listed in the Secondary Outcome Measure Section

Intervention Type OTHER

Quantitative Sensory testing

Summation pain threshold test and Heat pain threshold skin test

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hôpital Raymond Poincaré

OTHER

Sponsor Role collaborator

Bicetre Hospital

OTHER

Sponsor Role collaborator

Mikhail Dziadzko, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Mikhail Dziadzko, MD, PhD

Attending Pain Physician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hôpital Raymond Poincare - AP-HP

Garches, Hauts-de-Seine, France

Site Status

Hôpital Bicêtre AP-HP

Le Kremlin-Bicêtre, , France

Site Status

Hopital de la Croix Rousse - Hospices Civils de Lyon

Lyon, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 32644129 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32346843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32299017 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17500304 (View on PubMed)

Martinez V, Dziadzko M, Tamayo J, Schitter S, Guichard L, Richeux F, Roggerone S, Branche P, Schlaefflin L, Nacto Y, Antunes T, Negre I, Annane D, Aubrun F. Chronic pain characteristics in COVID-19 survivors after an ICU stay. A cross-sectional study. Anaesth Crit Care Pain Med. 2023 Dec;42(6):101267. doi: 10.1016/j.accpm.2023.101267. Epub 2023 Jun 24.

Reference Type DERIVED
PMID: 37356618 (View on PubMed)

Other Identifiers

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2020-A02929-30

Identifier Type: -

Identifier Source: org_study_id

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