Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome Caused by COVID-19 (RE-CoV-ERY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04619368
Recruitment Status : Recruiting
First Posted : November 6, 2020
Last Update Posted : November 6, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

For the last years, studies have described the " Post-intensive care Syndrome " (PICS), which consists in alteration of quality of life, cognition, autonomy and psychological disorders within the months after intensive-care. Patients with COVID-19 in intensive care units are at high risks to develop PICS.

The primary objective is to analyse the incidence of the post-traumatic stress disorder at 12 months after intensive-care for a COVID-19 Acute Respiratory Distress Syndrome (ARDS).


Condition or disease Intervention/treatment
Human ARDS Coronavirus Infection Other: Follow up calls

Detailed Description:

Many studies have showed that ARDS survivors keep, even a long time after hospitalization, a functional respiratory disability, resulting on one hand from impaired diffusion of carbon monoxide, and on the other hand from a muscular weakness. Indeed, 67% of patients ventilated more than 10 days have a neuromyopathy whose recovery is uncertain.

Beside this, Long-term quality of life is worse than in general population, due in particular to depressive and anxiety disorders such as post-traumatic syndrome disorder with a prevalence around 22% after one year.

The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Post-intensive Care Follow-up of Patients Hospitalized for an Acute Respiratory Distress Syndrome (ARDS) Caused by SARS-CoV-2 (COVID-19)
Actual Study Start Date : July 27, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Other: Follow up calls
    The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care [ Time Frame: month 12 ]
    Incidence of Post-traumatic Stress Disorder (PTSD) with the Post-traumatic Checklist-5 (PCL-5) 12 months after intensive-care


Secondary Outcome Measures :
  1. psychological disorders measured by QIDS [ Time Frame: Month 3 ]
    psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

  2. psychological disorders measured by STAI-YA [ Time Frame: Month 3 ]
    psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

  3. psychological disorders measured by QIDS [ Time Frame: Month 6 ]
    psychological disorders measured by QIDS : Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

  4. psychological disorders measured by STAI-YA [ Time Frame: Month 6 ]
    psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

  5. psychological disorders measured by QIDS [ Time Frame: Month 12 ]
    psychological disorders measured by QIDS, Quick Inventory of Depressive Symptomatology. results from 0 to 27; 27 is the higher score of depressive symptoms

  6. psychological disorders measured by STAI-YA [ Time Frame: Month 12 ]
    psychological disorders measured by STAI-YA, State Trait Inventory Anxiety. Results from 20 to 80. 80 is the higher score of anxiety

  7. quality of life by EQL-5 [ Time Frame: Month 3 ]
    Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life) higher score is higher quality of life

  8. quality of life by EQL-5 [ Time Frame: Month 6 ]
    Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life

  9. quality of life by EQL-5 [ Time Frame: Month 12 ]
    Quality of life measured by European Quality of Life -5 scale (overall satisfaction of Europeans concerning different aspects of life), higher score is higher quality of life

  10. nutritional status [ Time Frame: Month 3 ]
    nutritional status measured by Nutritional Risk Screening 2002

  11. nutritional status [ Time Frame: Month 6 ]
    nutritional status measured by Nutritional Risk Screening 2002

  12. nutritional status [ Time Frame: Month 12 ]
    nutritional status measured by Nutritional Risk Screening 2002


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
cohort of all COVID patients who went out alive from intensive care
Criteria

Inclusion Criteria:

  • adult patient
  • hospitalized in intensive care of the CHU anesthesia-intensive care unit (Rangueil, URM, Neurosurgery)
  • intubated and ventilated
  • supported for an ARDS according to the Berlin criteria (PaO2 / FiO2 ratio <300 mmHg)
  • with an rt-PCR positive to SARS-CoV-2
  • affiliated to the french social security

Exclusion Criteria:

  • minor patient
  • patient under protective measure
  • ARDS in the pandemic context but rt-PCR negative to SARS-CoV-2
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04619368


Contacts
Layout table for location contacts
Contact: Fanny BOUNES, PH 05 61 32 23 11 ext +33 Bounes.f@chu-toulouse.fr

Locations
Layout table for location information
France
University Hospital of Toulouse Recruiting
Toulouse, France, 31000
Contact: Fanny BOUNES, PH         
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Layout table for investigator information
Principal Investigator: Fanny BOUNES University Hospital, Toulouse
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT04619368    
Other Study ID Numbers: RC31/20/0219
First Posted: November 6, 2020    Key Record Dates
Last Update Posted: November 6, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Toulouse:
Post-intensive care Syndrome
Acute Respiratory Distress Syndrome
quality of life
intensive care unit
 PTSD
follow-up after ICU
COVID-19
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Coronaviridae Infections
Nidovirales Infections
 RNA Virus Infections
Virus Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Respiratory Tract Infections