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

November 29, 2023 updated by: Insel Gruppe AG, University Hospital Bern

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form (36) Health Survey (SF-36)
Time Frame: 3 months
Short Form (36) Health Survey (SF-36)
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: 90 days
Mortality
90 days
Modified Rankin Scale (mRS)
Time Frame: 90 days
Modified Rankin Scale (mRS); (0=no Symptoms at all, 6=dead)
90 days
Duration of mechanical ventilation in days
Time Frame: 3 months
Duration of mechanical ventilation in days
3 months
Barthel Index
Time Frame: 3 months
Barthel Index (80-100= patient should be able to live independently, <20=total dependence)
3 months
Beck's Depression Inventory II (BDI-II)
Time Frame: 3 months
Beck's Depression Inventory II (BDI-II)
3 months
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)
3 months
Number of patients with Critical Illness Myopathy
Time Frame: day 10
Number of patients with Critical Illness Myopathy
day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Insel Gruppe AG, University Hospital Bern

Investigators

  • Principal Investigator: Werner Z'Graggen, MD, Universitätsklinik für Neurochirurgie und Neurologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2020

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

November 27, 2023

Study Registration Dates

First Submitted

May 20, 2020

First Submitted That Met QC Criteria

May 20, 2020

First Posted (Actual)

May 21, 2020

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-00730

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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