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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336656
• Other study ID #: 251
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2023
• Source: Wilkes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The design for this study will be an international retrospective cohort trial. The investigators plan to recruit multiple sites to participate in the study through the use of professional organization list serves and contacts from an ongoing trial being conducted by the investigators (i.e. ALERT-ICU), as well as direct outreach to colleagues and associates of members of the investigator team. Data collection will be performed retrospectively utilizing the electronic medical record system at each participating institution. All data collection will be performed using REDCap, a secure web-based data collection tool that meets the HIPAA (Health Insurance Portability and Accountability Act of 1996) requirements for protection of patient health information. Data collected will include various site and patient demographic data. The investigators will also collect opioid and sedative doses, durations of therapy, weaning of doses, and withdrawal assessments.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 353
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All patients 18 years of age and older admitted to an adult intensive care unit who require invasive mechanical ventilation will be included if they meet one of the following additional criteria: 1. diagnosed with ARDS on or after January 1, 2019; 2. tested positive for COVID-19 and admitted on or after January 1, 2021. Consecutively admitted patients who meet inclusion criteria will be considered for enrollment.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Iatrogenic Disease
• Substance Withdrawal Syndrome
• Withdrawal Syndrome

Locations

Country	Name	City	State
United States	Wilkes University	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wilkes University

Country where clinical trial is conducted

United States, 

References & 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 — View Citation

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patterns of analgesia and sedation weaning as determined by a protocol	As a secondary outcome the investigators will evaluate patterns of analgesia and sedative weaning that may indicate the occurrence of withdrawal.	Three months