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Intensive Care Associated Complications and Outcome of Acute Respiratory Distress Syndrome Due to COVID-19

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ClinicalTrials.gov Identifier: NCT04397172
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital Inselspital, Berne

Brief Summary:

COVID-19 patients with a severely symptomatic progression with development of an Acute respiratory distress syndrome (ARDS) due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing Critical illness myopathy (CIM). CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using (Muscle velocity recovery cycles) MRVC measurements.

The primary endpoint is the incidence of CIM in patients with ARDS due to SARS-CoV-2, diagnosed according to the current diagnostic criteria.


Condition or disease Intervention/treatment
COVID Corona Virus Infection Sars-CoV2 Procedure: Study Arm

Detailed Description:

COVID-19 patients with a severely symptomatic progression with development of an ARDS due to SARS-CoV-2 need prolonged intensive care treatment involving pharmacological immobilization, sedation and mechanical ventilation, leaving them at a very high risk for developing CIM. CIM is associated with increased mortality and significant consequences for recovery and the ability to return to normal daily life. Up to date, there are no studies investigating the mid- or long-term course of the novel COVID-19 disease. The present study therefore aims to evaluate the clinical outcome of patients with ARDS due to SARS-CoV-2 with special attention to the development of CIM and its underlying causes. To provide the possibility of early diagnosis of CIM, critically ill patients will be regularly screened for muscle membrane alterations using MRVC measurements.

Objective:

The primary objective of this project is to prospectively evaluate the incidence and severity of CIM in patients with ARDS due to SARS-CoV-2.

The secondary objectives of this project include:

  1. To assess the quality of life of patients with and without CIM after ARDS due to SARS-CoV-2.
  2. To monitor changes in muscle excitability parameters in critically ill patients with ARDS due to SARS-CoV-2 in relation to a later confirmed diagnosis of CIM according to the current standards.
  3. To explore underlying pathophysiological processes for CIM (mitochondrial dysfunction, medication e.g. Neuromuscular blocking agents (NMBA), sedative drugs, and metabolic (amino acids, inflammatory parameters)).

Method:

After enrolment in the study, patients will be examined for the first time within 24 hours after admission to the ICU, and follow-up visits will be performed at day 2, 5 and 10 or upon termination of therapy with NMBA, respectively. The endpoint will be at the clinical follow-up appointment.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characterization of ARDS, Critical Illness Myopathy and Their Long-term Consequences in Patients With Covid-19 Disease: Effects of Inflammation, Mitochondrial Dysfunction and Plasma Concentrations of Various Sedative Drugs
Actual Study Start Date : April 9, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021



Intervention Details:
  • Procedure: Study Arm

    First inpatient examination (within 24 hours after admission to ICU):

    • Clinical examination
    • Laboratory tests, Biobanking, Mitochondrial function testing
    • Neurophysiological examination (MVRC recording)

    Follow-up inpatient examinations (day 2, 5 and 10 after admission):

    • Clinical examination
    • Laboratory tests, Biobanking, Mitochondrial functions testing
    • Neurophysiological examination (MVRC recording)
    • Day 10 only: Extended neurophysiological examination according to diagnostic criteria
    • Day 10 only: Grading of muscle strength (Medical Research Council (MRC) system)

    Follow-up outpatient examination (after discharge from intensive care):

    • Clinical examination
    • Grading of muscle strength (MRC)
    • Modified Rankin Scale (mRS)
    • Barthel Scale
    • Questionnaires (Short Form (36) Health Survey, Essener Questionnaire for Coping with a Disease and Beck's Depression Inventory II)


Primary Outcome Measures :
  1. Short Form (36) Health Survey (SF-36) [ Time Frame: 3 months ]
    Short Form (36) Health Survey (SF-36)


Secondary Outcome Measures :
  1. Mortality [ Time Frame: 90 days ]
    Mortality

  2. Modified Rankin Scale (mRS) [ Time Frame: 90 days ]
    Modified Rankin Scale (mRS); (0=no Symptoms at all, 6=dead)

  3. Duration of mechanical ventilation in days [ Time Frame: 3 months ]
    Duration of mechanical ventilation in days

  4. Barthel Index [ Time Frame: 3 months ]
    Barthel Index (80-100= patient should be able to live independently, <20=total dependence)

  5. Beck's Depression Inventory II (BDI-II) [ Time Frame: 3 months ]
    Beck's Depression Inventory II (BDI-II)

  6. Essener Questionnaire for Coping with a Disease (EFK) [ Time Frame: 3 months ]
    Essener Questionnaire for Coping with a Disease (EFK); (0=no burden of disease, 180-strong burden of disease)

  7. Number of patients with Critical Illness Myopathy [ Time Frame: day 10 ]
    Number of patients with Critical Illness Myopathy



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The present study aims to prospectively evaluate the incidence and severity of CIM in patients with ARDS due to SARS-CoV-2.

The investigators therefore conduct a study including patients with ARDS admitted to the intensive care unit (ICU) due to the novel COVID-19 disease (SARS-CoV-2). The investigators plan to analyze 50 full data sets of ICU patients (regarding primary endpoint), out of which about 30-50% will be expected to develop CIM. There is no alternative group of patients with whom this study could be conducted.

Criteria

Inclusion Criteria:

  • Informed consent as documented by a surrogate assessment by an independent physician
  • Adult ICU Patients with ARDS due to SARS-CoV-2 requiring mechanical ventilation

Exclusion Criteria:

  • Age <18 years and > 80 years
  • Pregnancy and breast feeding
  • The presence of pre-existing:

    • Known (at time of inclusion) Polyneuropathy,
    • Known (at time of inclusion) Guillain-Barré syndrome,
    • Known (at time of inclusion) Acute or chronic spinal cord lesion,
    • Known (at time of inclusion) Myasthenia gravis, or
    • Known (at time of inclusion) Myopathy

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): NCT04397172


Contacts
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Contact: Werner Z'Graggen, MD +41316327909 werner.zgraggen@insel.ch
Contact: Nicoles Söll +41316323164 nicole.soell@insel.ch

Locations
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Switzerland
Inselspital Bern Recruiting
Bern, Switzerland, 3010
Contact: Werner Z'Graggen, MD    +41 31 632 79 09    werner.zgraggen@insel.ch   
Contact: Nicole Söll    +41 31 632 00 14    nicole.soell@insel.ch   
Principal Investigator: Werner Z'Graggen, MD         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
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Principal Investigator: Werner Z'Graggen, MD Universitätsklinik für Neurochirurgie und Neurologie
Publications:

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Responsible Party: University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT04397172    
Other Study ID Numbers: 2020-00730
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Inselspital, Berne:
Corona
SARS-CoV2
ARDS
PICS
Additional relevant MeSH terms:
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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections