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

April 24, 2023 updated by: Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP, Wilkes University

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

353

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wilkes-Barre, Pennsylvania, United States, 18701
        • Wilkes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in cumulative analgesia and sedation dose in appropriate units (e.g. mg, micrograms, etc.)
Time Frame: Three months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patterns of analgesia and sedation weaning as determined by a protocol
Time Frame: Three months
As a secondary outcome the investigators will evaluate patterns of analgesia and sedative weaning that may indicate the occurrence of withdrawal.
Three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wilkes University

Investigators

  • Study Director: 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 Chair: Nash Wenner, Student, Wilkes University
  • Study Chair: Jaycee Blair, Student, Wilkes University
  • Study Chair: Faizan Ali, Student, Wilkes University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

December 31, 2022

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 18, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 251 (PEIBA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan is to share individual participant data specific to each institution through data access groups in RedCap

IPD Sharing Time Frame

Twelve months after data collection completed

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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