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

NCT ID: NCT04422808

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2437 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2022-04-01

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.

Detailed Description

The design for this study will be an international, prospective, observational, point prevalence trial. The investigators plan to recruit multiple sites to participate in the study through the use of professional organization list serves as well as direct outreach to colleagues and associates of members of the investigator team. Data collection will be performed by site investigators on one single day for all patients currently in the ICU who meet inclusion criteria on the data collection day. Site investigators will have an approximately three-month time frame in which to choose a data collection date. 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. Utilization of this system will allow real-time input of data from the patient's bedside by site investigators. 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 assessment results.

Conditions

Withdrawal Syndrome; Iatrogenic Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wilkes University

OTHER

Sponsor Role: lead

Responsible Party

Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilles L Fraser, PharmD, MCCM

Role: STUDY_DIRECTOR

Tufts University School of Medicine

Scott Bolesta, PharmD, BCPS

Role: PRINCIPAL_INVESTIGATOR

Wilkes University

Marc M Perreault, MSc, PharmD

Role: STUDY_DIRECTOR

Université de Montréal

Lisa Burry, PharmD

Role: STUDY_DIRECTOR

MOUNT SINAI HOSPITAL

Brian L Erstad, PharmD, MCCM

Role: STUDY_DIRECTOR

The University of Arizona College of Pharmacy

Céline Gélinas, N., Ph.D.

Role: STUDY_DIRECTOR

Ingram School of Nursing

Richard R Riker, MD, FCCM

Role: STUDY_DIRECTOR

Tufts University School of Medicine

Katrianna D Saltarelli, Student

Role: STUDY_CHAIR

Wilkes University

Jennifer Mitchell, Student

Role: STUDY_CHAIR

Wilkes University

Kathryn E Smith, PharmD, BCPS, BCCCP

Role: STUDY_DIRECTOR

MaineHealth

Federico Carini, MD

Role: STUDY_DIRECTOR

Hospital Italiano de Buenos Aires

Rebekah Eadie, MPharm, MSc, IP, MPSNI

Role: STUDY_DIRECTOR

Ulster Hospital- South Eastern Health and Social Care Board

Jamie Harpel, Student

Role: STUDY_CHAIR

Wilkes University

Ryan Stewart, Student

Role: STUDY_CHAIR

Wilkes University

Locations

Wilkes University

Wilkes-Barre, Pennsylvania, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 29292273 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10776874 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9559604 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28793780 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25602358 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30569508 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9934916 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28866754 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37283558 (View on PubMed)

Other Identifiers

116

Identifier Type: -

Identifier Source: org_study_id