Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19

NCT05336656 | Completed

• 1 other identifier: 251
• Study Type: observational
• Target: 353
• Locations: 1 country
• Sites: 1

Brief Summary

The analgesic and sedation requirements in critically ill patients with COVID-19 have yet to be described. There are various factors that are likely affecting the agents being utilized for analgesia and sedation in these patients with little evidence to guide therapy. In addition, such non-evidence based practice may be leading to an increased incidence of iatrogenic withdrawal. The investigators seek to determine the analgesia and sedation requirements in critically ill patients with COVID-19 and report practice patterns that may be associated with iatrogenic withdrawal in these patients. The contribution of the proposed research will be an understanding of current analgesia and sedation use and weaning in critically ill patients with COVID-19, and practice patterns that may indicate the occurrence of iatrogenic withdrawal. This contribution will be significant because it will determine how analgesics and sedatives are being utilized in critically ill patients with COVID-19, and how their use may be leading to additional morbidity. Data from this initial trial will help support further research on the actual incidence of iatrogenic withdrawal in this patient population. Together such research will help inform practice patterns and therapy recommendations in advance of the next SARS-related outbreak.

Conditions

COVID-19; ARDS; Withdrawal Syndrome; Iatrogenic Disease

Keywords

Opioid Withdrawal; Benzodiazepine Withdrawal; Narcotic Withdrawal; Critically ill

Outcome Measures

Primary Outcomes (1)

• Difference in cumulative analgesia and sedation dose in appropriate units (e.g. mg, micrograms, etc.)

  The primary outcome will be the difference in cumulative analgesia and sedation dose 72 hours after ICU admission of patients with ARDS compared to patients with COVID-19. The investigators will compare the groups for differences in types of agents utilized, doses (both average and cumulative) and duration. An additional primary outcome will be the differences in analgesia and sedation weaning requirements between patients with ARDS and COVID-19. Specifically, the investigators will evaluate dosing of analgesics and sedatives during weaning and the use of adjuvant agents (e.g. clonidine) and alternate routes of administration (e.g. oral benzodiazepines).

  Three months

Secondary Outcomes (1)

• Patterns of analgesia and sedation weaning as determined by a protocol

  Three months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The investigators anticipate involvement of 30 intensive care unit centers within the United States, Canada, Europe, South America, and Middle East. Each site will contribute 10 patients who meet study criteria.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded: surgical and trauma patients, admitted for cardiac arrest, admitted with a primary acute vascular event (e.g. ACS, stroke, etc.), brain injury and/or cerebral edema (e.g. traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage, etc.), admitted for status epilepticus, pregnant, receiving extracorporeal membrane oxygenation support.

Sponsors & Collaborators

• Wilkes University: lead

Study Sites (1)

Wilkes University

Wilkes-Barre, Pennsylvania, 18701, United States

Location

Related Publications (6)

• Alhazzani W, Moller MH, Arabi YM, Loeb M, Gong MN, Fan E, Oczkowski S, Levy MM, Derde L, Dzierba A, Du B, Aboodi M, Wunsch H, Cecconi M, Koh Y, Chertow DS, Maitland K, Alshamsi F, Belley-Cote E, Greco M, Laundy M, Morgan JS, Kesecioglu J, McGeer A, Mermel L, Mammen MJ, Alexander PE, Arrington A, Centofanti JE, Citerio G, Baw B, Memish ZA, Hammond N, Hayden FG, Evans L, Rhodes A. Surviving Sepsis Campaign: guidelines on the management of critically ill adults with Coronavirus Disease 2019 (COVID-19). Intensive Care Med. 2020 May;46(5):854-887. doi: 10.1007/s00134-020-06022-5. Epub 2020 Mar 28.

  PMID: 32222812 RESULT

• Devlin JW, Skrobik Y, Gelinas C, Needham DM, Slooter AJC, Pandharipande PP, Watson PL, Weinhouse GL, Nunnally ME, Rochwerg B, Balas MC, van den Boogaard M, Bosma KJ, Brummel NE, Chanques G, Denehy L, Drouot X, Fraser GL, Harris JE, Joffe AM, Kho ME, Kress JP, Lanphere JA, McKinley S, Neufeld KJ, Pisani MA, Payen JF, Pun BT, Puntillo KA, Riker RR, Robinson BRH, Shehabi Y, Szumita PM, Winkelman C, Centofanti JE, Price C, Nikayin S, Misak CJ, Flood PD, Kiedrowski K, Alhazzani W. Clinical Practice Guidelines for the Prevention and Management of Pain, Agitation/Sedation, Delirium, Immobility, and Sleep Disruption in Adult Patients in the ICU. Crit Care Med. 2018 Sep;46(9):e825-e873. doi: 10.1097/CCM.0000000000003299.

  PMID: 30113379 RESULT

• Hanidziar D, Bittner EA. Sedation of Mechanically Ventilated COVID-19 Patients: Challenges and Special Considerations. Anesth Analg. 2020 Jul;131(1):e40-e41. doi: 10.1213/ANE.0000000000004887. No abstract available.

  PMID: 32392023 RESULT

• Kahn JM, Andersson L, Karir V, Polissar NL, Neff MJ, Rubenfeld GD. Low tidal volume ventilation does not increase sedation use in patients with acute lung injury. Crit Care Med. 2005 Apr;33(4):766-71. doi: 10.1097/01.ccm.0000157786.41506.24.

  PMID: 15818103 RESULT

• Marini JJ, Gattinoni L. Management of COVID-19 Respiratory Distress. JAMA. 2020 Jun 9;323(22):2329-2330. doi: 10.1001/jama.2020.6825. No abstract available.

  PMID: 32329799 RESULT

• Witenko CJ, Littlefield AJ, Abedian S, An A, Barie PS, Berger K. The Safety of Continuous Infusion Propofol in Mechanically Ventilated Adults With Coronavirus Disease 2019. Ann Pharmacother. 2022 Jan;56(1):5-15. doi: 10.1177/10600280211017315. Epub 2021 May 14.

  PMID: 33985368 RESULT

MeSH Terms

Conditions

COVID-19; Substance Withdrawal Syndrome; Iatrogenic Disease; Critical Illness

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc M Perreault, MSc, PharmD, BCPS, FSCPH, FOPQ

  Université de Montréal

  STUDY DIRECTOR

• Lisa Burry, PharmD, FCCP, FCCM, PhD

  MOUNT SINAI HOSPITAL

  STUDY DIRECTOR

• Céline Gélinas, RN, PhD

  Ingram School of Nursing

  STUDY DIRECTOR

• Kathryn E Smith, PharmD, BCPS, BCCCP

  Maine Health

  STUDY DIRECTOR

• Nash Wenner, Student

  Wilkes University

  STUDY CHAIR

• Jaycee Blair, Student

  Wilkes University

  STUDY CHAIR

• Faizan Ali, Student

  Wilkes University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 20, 2022
• Study Start: January 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Twelve months after data collection completed
• Access Criteria: Individual site data will be accessible to each specific participating study site. Only site investigators will have access to their study site data.

Locations

US (1)