COVID-19NCT05336656
Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
An observational study of COVID-19 and ARDS, run by Wilkes University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COVID-19, ARDS, Withdrawal Syndrome
- How many people
- 353 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2022to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- COVID-19, ARDS, Withdrawal Syndrome, Iatrogenic Disease
- Keywords
- Opioid Withdrawal, Benzodiazepine Withdrawal, Narcotic Withdrawal, Critically ill
- Medical subject headings
- COVID-19, Substance Withdrawal Syndrome, Iatrogenic Disease, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Three months
Secondary outcomes (1)
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.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Jan 2022
- Primary completion30 Nov 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 353 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wilkes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP, Wilkes University
- Investigators
- Marc M Perreault, MSc, PharmD, BCPS, FSCPH, FOPQ, Study director, Université de MontréalLisa Burry, PharmD, FCCP, FCCM, PhD, Study director, MOUNT SINAI HOSPITALCéline Gélinas, RN, PhD, Study director, Ingram School of NursingKathryn E Smith, PharmD, BCPS, BCCCP, Study director, Maine HealthNash Wenner, Student, Study chair, Wilkes UniversityJaycee Blair, Student, Study chair, Wilkes UniversityFaizan Ali, Student, Study chair, Wilkes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336656
- Sponsor's protocol ID
- 251
- Status last verified
- Apr 2023
- First submitted
- 18 Apr 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan is to share individual participant data specific to each institution through data access groups in RedCap
Publications
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.
PubMed 32222812Devlin 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.
PubMed 30113379Hanidziar 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.
PubMed 32392023Kahn 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.
PubMed 15818103Marini 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.
PubMed 32329799Witenko 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.
PubMed 33985368
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Analgesics and Sedatives in Mechanically Ventilated Patients With COVID-19
- ClinicalTrials.gov ID
- NCT05336656
- Acronym / sponsor ID
- 251
- Conditions
- COVID-19, ARDS, Withdrawal Syndrome, Iatrogenic Disease
- Keywords
- Opioid Withdrawal, Benzodiazepine Withdrawal, Narcotic Withdrawal, Critically ill
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 353 participants (actual)
- Lead sponsor
- Wilkes UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Patterns of analgesia and sedation weaning as determined by a protocol
Time frame: Three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Results publication: PubMed 32222812Alhazzani 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.
- Results publication: PubMed 30113379Devlin 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.
- Results publication: PubMed 32392023Hanidziar 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.
- Results publication: PubMed 15818103Kahn 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.
- Results publication: PubMed 32329799Marini 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.
- Results publication: PubMed 33985368Witenko 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.
- Individual participant dataSharing planned: Yes. Plan is to share individual participant data specific to each institution through data access groups in RedCap
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc M Perreault, MSc, PharmD, BCPS, FSCPH, FOPQ study director
Université de Montréal
Lisa Burry, PharmD, FCCP, FCCM, PhD study director
MOUNT SINAI HOSPITAL
Céline Gélinas, RN, PhD study director
Ingram School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and ARDS, run by Wilkes University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in cumulative analgesia and sedation dose in appropriate units (e.g. mg, micrograms, etc.) (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05336656, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.