NCT04422808|Completed
AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU)
Assessing Current Analgesia and Sedation Weaning Practices in Adult Critically Ill Patients
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Assessing Current Analgesia and Sedation Weaning Practices in Adult Critically Ill Patients
Sponsor study identifier
observational
2,437
1 country
1
Study Start
June 1, 2021
Actual (reported)Primary Completion
September 30, 2021
Actual (reported)Study Completion
April 1, 2022
Actual (reported)Withdrawal from opioids and sedatives administered for medical purposes (i.e. iatrogenic withdrawal) often goes unrecognized in the critically ill, but its prevalence is high. Reports describing what is being implemented at the bedside to prevent iatrogenic withdrawal are lacking, and how patients are monitored and assessed for withdrawal has not been adequately studied. Therefore, the investigators overall objective is to determine the current analgesia and sedation weaning practices in adult ICUs. In order to accomplish this objective the investigators plan to conduct a prospective, observational, point prevalence trial. Data from this project will help support future investigation of iatrogenic withdrawal.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2022
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2020
Actual (reported)June 9, 2020
Actual (reported)June 1, 2021
Actual (reported)September 30, 2021
Actual (reported)April 1, 2022
Actual (reported)Number patients weaned from parenteral analgesics
The primary outcome will be the number of patients who are weaned from continuous parenteral analgesics and sedatives using a standardized approach. Continuous analgesic and sedative administration will be defined as those given as a continuous intravenous infusion, scheduled intermittent intravenous or subcutaneous injections, or as needed with at least half of the possible doses in a 24 hour period being administered.
Three months
Patient proportion
Three months
Utilized analgesic and sedative weaning practice
three months
Number of patients assessed
three months
Assessment tools
three months
Standardized approach patients
three months
We anticipate the involvement of at least 50 intensive care unit centers within the United States, and less than 10 sites outside the United States (primarily in Canada, Australia, Europe, and the Middle East). Estimating an average of 10 patients who meet study criteria at each site.
Wilkes University
Wilkes-Barre, Pennsylvania, 18701-1013, United States
Borkowska M, Labeau S, Schepens T, Vandijck D, Van de Vyver K, Christiaens D, Lizy C, Blackwood B, Blot SI. Nurses' Sedation Practices During Weaning of Adults From Mechanical Ventilation in an Intensive Care Unit. Am J Crit Care. 2018 Jan;27(1):32-42. doi: 10.4037/ajcc2018959.
Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1.
Gilles L Fraser, PharmD, MCCM
Tufts University School of Medicine
Scott Bolesta, PharmD, BCPS
Wilkes University
Marc M Perreault, MSc, PharmD
Université de Montréal
Lisa Burry, PharmD
MOUNT SINAI HOSPITAL
2,437 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2020
First Posted
June 9, 2020
Study Start
June 1, 2021
Actual (reported)Kratom Use Disorder Management Using Clonidine and/or Buprenorphine
Contact the study team to confirm eligibility.
Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015.
Chiu AW, Contreras S, Mehta S, Korman J, Perreault MM, Williamson DR, Burry LD. Iatrogenic Opioid Withdrawal in Critically Ill Patients: A Review of Assessment Tools and Management. Ann Pharmacother. 2017 Dec;51(12):1099-1111. doi: 10.1177/1060028017724538. Epub 2017 Aug 9.
Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399.
Duceppe MA, Perreault MM, Frenette AJ, Burry LD, Rico P, Lavoie A, Gelinas C, Mehta S, Dagenais M, Williamson DR. Frequency, risk factors and symptomatology of iatrogenic withdrawal from opioids and benzodiazepines in critically Ill neonates, children and adults: A systematic review of clinical studies. J Clin Pharm Ther. 2019 Apr;44(2):148-156. doi: 10.1111/jcpt.12787. Epub 2018 Dec 19.
Fonsmark L, Rasmussen YH, Carl P. Occurrence of withdrawal in critically ill sedated children. Crit Care Med. 1999 Jan;27(1):196-9. doi: 10.1097/00003246-199901000-00052.
Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5.
Bolesta S, Burry L, Perreault MM, Gelinas C, Smith KE, Eadie R, Carini FC, Saltarelli K, Mitchell J, Harpel J, Stewart R, Riker RR, Fraser GL, Erstad BL; AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU) Study Investigators. International Analgesia and Sedation Weaning and Withdrawal Practices in Critically Ill Adults: The Adult Iatrogenic Withdrawal Study in the ICU. Crit Care Med. 2023 Nov 1;51(11):1502-1514. doi: 10.1097/CCM.0000000000005951. Epub 2023 Jun 7.
Brian L Erstad, PharmD, MCCM
The University of Arizona College of Pharmacy
Céline Gélinas, N., Ph.D.
Ingram School of Nursing
Richard R Riker, MD, FCCM
Tufts University School of Medicine
Katrianna D Saltarelli, Student
Wilkes University
Jennifer Mitchell, Student
Wilkes University
Kathryn E Smith, PharmD, BCPS, BCCCP
MaineHealth
Federico Carini, MD
Hospital Italiano de Buenos Aires
Rebekah Eadie, MPharm, MSc, IP, MPSNI
Ulster Hospital- South Eastern Health and Social Care Board
Jamie Harpel, Student
Wilkes University
Ryan Stewart, Student
Wilkes University
Primary Completion
September 30, 2021
Actual (reported)Study Completion
April 1, 2022
Actual (reported)Last Updated
July 29, 2022
Record last verified: 2022-07
Plan is to share individual participant data specific to each institution through data access groups in RedCap
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Source: ClinicalTrials.gov.
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