AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU)

NCT04422808 | Completed

• 1 other identifier: 116
• Study Type: observational
• Target: 2,437
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Withdrawal Syndrome; Iatrogenic Disease

Keywords

Opioid withdrawal; Benzodiazepine withdrawal; Narcotic withdrawal; Critically ill

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• All patients 18 years and older admitted to an adult intensive care unit on the day of data collection who have received parenteral analgesics or sedatives in the previous 24 hours.

You may not qualify if:

• Patients who have not received parenteral analgesics or sedatives in the previous 24 hours.

Sponsors & Collaborators

• Wilkes University: lead

Study Sites (1)

Wilkes University

Wilkes-Barre, Pennsylvania, 18701-1013, United States

Location

Related Publications (9)

• 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.

  PMID: 29292273 RESULT

• 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.

  PMID: 10776874 RESULT

• 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.

  PMID: 9559604 RESULT

• 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.

  PMID: 28793780 RESULT

• 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.

  PMID: 25602358 RESULT

• 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.

  PMID: 30569508 RESULT

• 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.

  PMID: 9934916 RESULT

• 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.

  PMID: 28866754 RESULT

• 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.

  PMID: 37283558 DERIVED

MeSH Terms

Conditions

Substance Withdrawal Syndrome; Iatrogenic Disease; Critical Illness

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gilles L Fraser, PharmD, MCCM

  Tufts University School of Medicine

  STUDY DIRECTOR

• Scott Bolesta, PharmD, BCPS

  Wilkes University

  PRINCIPAL INVESTIGATOR

• Marc M Perreault, MSc, PharmD

  Université de Montréal

  STUDY DIRECTOR

• Lisa Burry, PharmD

  MOUNT SINAI HOSPITAL

  STUDY DIRECTOR

• Brian L Erstad, PharmD, MCCM

  The University of Arizona College of Pharmacy

  STUDY DIRECTOR

• Céline Gélinas, N., Ph.D.

  Ingram School of Nursing

  STUDY DIRECTOR

• Richard R Riker, MD, FCCM

  Tufts University School of Medicine

  STUDY DIRECTOR

• Katrianna D Saltarelli, Student

  Wilkes University

  STUDY CHAIR

• Jennifer Mitchell, Student

  Wilkes University

  STUDY CHAIR

• Kathryn E Smith, PharmD, BCPS, BCCCP

  MaineHealth

  STUDY DIRECTOR

• Federico Carini, MD

  Hospital Italiano de Buenos Aires

  STUDY DIRECTOR

• Rebekah Eadie, MPharm, MSc, IP, MPSNI

  Ulster Hospital- South Eastern Health and Social Care Board

  STUDY DIRECTOR

• Jamie Harpel, Student

  Wilkes University

  STUDY CHAIR

• Ryan Stewart, Student

  Wilkes University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 4, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: April 1, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)