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

Terminated

• Conditions: Sars-CoV2; COVID; Corona Virus Infection

• Registration Number: NCT04397172
• Lead Sponsor: Insel Gruppe AG, University Hospital Bern

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.

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 Timeline

• Study Start: 2020-04-09
• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-21
• Primary Completion: 2023-10-31
• Status Verified: 2023-11
• Study Completion: 2023-11-27
• Last Update Submitted: 2023-11-29
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short Form (36) Health Survey (SF-36)	3 months	Short Form (36) Health Survey (SF-36)

Secondary Outcome Measures

Name	Time	Method
Barthel Index	3 months	Barthel Index (80-100= patient should be able to live independently, \<20=total dependence)
Modified Rankin Scale (mRS)	90 days	Modified Rankin Scale (mRS); (0=no Symptoms at all, 6=dead)
Duration of mechanical ventilation in days	3 months	Duration of mechanical ventilation in days
Beck's Depression Inventory II (BDI-II)	3 months	Beck's Depression Inventory II (BDI-II)
Number of patients with Critical Illness Myopathy	day 10	Number of patients with Critical Illness Myopathy
Mortality	90 days	Mortality
Essener Questionnaire for Coping with a Disease (EFK)	3 months	Essener Questionnaire for Coping with a Disease (EFK); (0=no burden of disease, 180-strong burden of disease)

Trial Locations

Locations (1)

Inselspital Bern; 🇨🇭 Bern, Switzerland