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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05336656
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2022
Last Update Posted : April 27, 2022
Sponsor:
Information provided by (Responsible Party):
Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP, Wilkes University

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.


Condition or disease
COVID-19 ARDS Withdrawal Syndrome Iatrogenic Disease

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.

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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Retrospective
Official Title: Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
Actual Study Start Date : January 1, 2022
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05336656


Locations
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United States, Pennsylvania
Wilkes University
Wilkes-Barre, Pennsylvania, United States, 18701
Sponsors and Collaborators
Wilkes University
Investigators
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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 of Results:

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Responsible Party: Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP, Associate Professor, Wilkes University
ClinicalTrials.gov Identifier: NCT05336656    
Other Study ID Numbers: 251
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: April 27, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan is to share individual participant data specific to each institution through data access groups in RedCap
Supporting Materials: Study Protocol
Statistical Analysis Plan (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.


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP, Wilkes University:
Opioid Withdrawal
Benzodiazepine Withdrawal
Narcotic Withdrawal
Critically ill
Additional relevant MeSH terms:
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COVID-19
Iatrogenic Disease
Substance Withdrawal Syndrome
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
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