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

NCT04397172 | Terminated

• 1 other identifier: 2020-00730
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Corona Virus Infection; Sars-CoV2

Keywords

Corona; SARS-CoV2; ARDS; PICS

Outcome Measures

Primary Outcomes (1)

• Short Form (36) Health Survey (SF-36)

  Short Form (36) Health Survey (SF-36)

  3 months

Secondary Outcomes (7)

• Mortality

  90 days

• Modified Rankin Scale (mRS)

  90 days

• Duration of mechanical ventilation in days

  3 months

• Barthel Index

  3 months

• Beck's Depression Inventory II (BDI-II)

  3 months

Interventions

Study Arm PROCEDURE

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)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

Location

Related Publications (15)

• Belgnaoui SM, Paz S, Hiscott J. Orchestrating the interferon antiviral response through the mitochondrial antiviral signaling (MAVS) adapter. Curr Opin Immunol. 2011 Oct;23(5):564-72. doi: 10.1016/j.coi.2011.08.001. Epub 2011 Aug 22.

  PMID: 21865020 BACKGROUND

• Chen N, Zhou M, Dong X, Qu J, Gong F, Han Y, Qiu Y, Wang J, Liu Y, Wei Y, Xia J, Yu T, Zhang X, Zhang L. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study. Lancet. 2020 Feb 15;395(10223):507-513. doi: 10.1016/S0140-6736(20)30211-7. Epub 2020 Jan 30.

  PMID: 32007143 BACKGROUND

• Dinglas VD, Aronson Friedman L, Colantuoni E, Mendez-Tellez PA, Shanholtz CB, Ciesla ND, Pronovost PJ, Needham DM. Muscle Weakness and 5-Year Survival in Acute Respiratory Distress Syndrome Survivors. Crit Care Med. 2017 Mar;45(3):446-453. doi: 10.1097/CCM.0000000000002208.

  PMID: 28067712 BACKGROUND

• De Jonghe B, Sharshar T, Lefaucheur JP, Authier FJ, Durand-Zaleski I, Boussarsar M, Cerf C, Renaud E, Mesrati F, Carlet J, Raphael JC, Outin H, Bastuji-Garin S; Groupe de Reflexion et d'Etude des Neuromyopathies en Reanimation. Paresis acquired in the intensive care unit: a prospective multicenter study. JAMA. 2002 Dec 11;288(22):2859-67. doi: 10.1001/jama.288.22.2859.

  PMID: 12472328 BACKGROUND

• de Letter MA, Schmitz PI, Visser LH, Verheul FA, Schellens RL, Op de Coul DA, van der Meche FG. Risk factors for the development of polyneuropathy and myopathy in critically ill patients. Crit Care Med. 2001 Dec;29(12):2281-6. doi: 10.1097/00003246-200112000-00008.

  PMID: 11801825 BACKGROUND

• Griffiths J, Hatch RA, Bishop J, Morgan K, Jenkinson C, Cuthbertson BH, Brett SJ. An exploration of social and economic outcome and associated health-related quality of life after critical illness in general intensive care unit survivors: a 12-month follow-up study. Crit Care. 2013 May 28;17(3):R100. doi: 10.1186/cc12745.

  PMID: 23714692 BACKGROUND

• Herridge MS, Tansey CM, Matte A, Tomlinson G, Diaz-Granados N, Cooper A, Guest CB, Mazer CD, Mehta S, Stewart TE, Kudlow P, Cook D, Slutsky AS, Cheung AM; Canadian Critical Care Trials Group. Functional disability 5 years after acute respiratory distress syndrome. N Engl J Med. 2011 Apr 7;364(14):1293-304. doi: 10.1056/NEJMoa1011802.

  PMID: 21470008 BACKGROUND

• James MA. Use of the Medical Research Council muscle strength grading system in the upper extremity. J Hand Surg Am. 2007 Feb;32(2):154-6. doi: 10.1016/j.jhsa.2006.11.008. No abstract available.

  PMID: 17275587 BACKGROUND

• Lacomis D. Electrophysiology of neuromuscular disorders in critical illness. Muscle Nerve. 2013 Mar;47(3):452-63. doi: 10.1002/mus.23615. Epub 2013 Feb 6.

  PMID: 23386582 BACKGROUND

• Latronico N, Bolton CF. Critical illness polyneuropathy and myopathy: a major cause of muscle weakness and paralysis. Lancet Neurol. 2011 Oct;10(10):931-41. doi: 10.1016/S1474-4422(11)70178-8.

  PMID: 21939902 BACKGROUND

• Liu Y, Yan LM, Wan L, Xiang TX, Le A, Liu JM, Peiris M, Poon LLM, Zhang W. Viral dynamics in mild and severe cases of COVID-19. Lancet Infect Dis. 2020 Jun;20(6):656-657. doi: 10.1016/S1473-3099(20)30232-2. Epub 2020 Mar 19. No abstract available.

  PMID: 32199493 BACKGROUND

• Shi CS, Qi HY, Boularan C, Huang NN, Abu-Asab M, Shelhamer JH, Kehrl JH. SARS-coronavirus open reading frame-9b suppresses innate immunity by targeting mitochondria and the MAVS/TRAF3/TRAF6 signalosome. J Immunol. 2014 Sep 15;193(6):3080-9. doi: 10.4049/jimmunol.1303196. Epub 2014 Aug 18.

  PMID: 25135833 BACKGROUND

• Weber-Carstens S, Deja M, Koch S, Spranger J, Bubser F, Wernecke KD, Spies CD, Spuler S, Keh D. Risk factors in critical illness myopathy during the early course of critical illness: a prospective observational study. Crit Care. 2010;14(3):R119. doi: 10.1186/cc9074. Epub 2010 Jun 18.

  PMID: 20565863 BACKGROUND

• Xu Z, Shi L, Wang Y, Zhang J, Huang L, Zhang C, Liu S, Zhao P, Liu H, Zhu L, Tai Y, Bai C, Gao T, Song J, Xia P, Dong J, Zhao J, Wang FS. Pathological findings of COVID-19 associated with acute respiratory distress syndrome. Lancet Respir Med. 2020 Apr;8(4):420-422. doi: 10.1016/S2213-2600(20)30076-X. Epub 2020 Feb 18. No abstract available.

  PMID: 32085846 BACKGROUND

• Z'Graggen WJ, Brander L, Tuchscherer D, Scheidegger O, Takala J, Bostock H. Muscle membrane dysfunction in critical illness myopathy assessed by velocity recovery cycles. Clin Neurophysiol. 2011 Apr;122(4):834-41. doi: 10.1016/j.clinph.2010.09.024. Epub 2010 Nov 1.

  PMID: 21044861 BACKGROUND

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Werner Z'Graggen, MD

  Universitätsklinik für Neurochirurgie und Neurologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 21, 2020
• Study Start: April 9, 2020
• Primary Completion: October 31, 2023
• Study Completion: November 27, 2023
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

CH (1)