Clinical trial NCT05336656: Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
Official title: Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
ARDS
Withdrawal Syndrome
Iatrogenic Disease
Keywords: Opioid Withdrawal
Benzodiazepine Withdrawal
Narcotic Withdrawal
Critically ill
Lead sponsor: Wilkes University
Sponsor class: OTHER
First posted: 2022-04-20
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Difference in cumulative analgesia and sedation dose in appropriate units (e.g. mg, micrograms, etc.)
timeFrame: Three months
Secondary outcomes:
measure: Patterns of analgesia and sedation weaning as determined by a protocol
timeFrame: Three months
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Wilkes University
state: Pennsylvania
Study officials:
affiliation: Université de Montréal
name: Marc M Perreault, MSc, PharmD, BCPS, FSCPH, FOPQ
role: STUDY_DIRECTOR
affiliation: MOUNT SINAI HOSPITAL
name: Lisa Burry, PharmD, FCCP, FCCM, PhD
role: STUDY_DIRECTOR
affiliation: Ingram School of Nursing
name: Céline Gélinas, RN, PhD
role: STUDY_DIRECTOR
affiliation: Maine Health
name: Kathryn E Smith, PharmD, BCPS, BCCCP
role: STUDY_DIRECTOR
affiliation: Wilkes University
name: Nash Wenner, Student
role: STUDY_CHAIR
affiliation: Wilkes University
name: Jaycee Blair, Student
role: STUDY_CHAIR
affiliation: Wilkes University
name: Faizan Ali, Student
role: STUDY_CHAIR
References:
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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.
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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.
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 May 14.