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

NCT04397172 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2023-12-06

No results posted yet for this study

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.

Conditions

  • COVID
  • Corona Virus Infection
  • Sars-CoV2

Interventions

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)

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Werner Z'Graggen, MD · Universitätsklinik für Neurochirurgie und Neurologie

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-09
Primary Completion
2023-10-31
Completion
2023-11-27

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04397172 on ClinicalTrials.gov