Clinical trial NCT04422808: AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU)
Official title: Assessing Current Analgesia and Sedation Weaning Practices in Adult Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Withdrawal Syndrome
Iatrogenic Disease
Keywords: Opioid withdrawal
Benzodiazepine withdrawal
Narcotic withdrawal
Critically ill
Lead sponsor: Wilkes University
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 2437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Number patients weaned from parenteral analgesics
timeFrame: Three months
Secondary outcomes:
measure: Patient proportion
timeFrame: Three months
measure: Utilized analgesic and sedative weaning practice
timeFrame: three months
measure: Number of patients assessed
timeFrame: three months
measure: Assessment tools
timeFrame: three months
measure: Standardized approach patients
timeFrame: three months
Other outcomes:
Locations:
city: Wilkes-Barre
country: United States
facility: Wilkes University
state: Pennsylvania
Study officials:
affiliation: Tufts University School of Medicine
name: Gilles L Fraser, PharmD, MCCM
role: STUDY_DIRECTOR
affiliation: Wilkes University
name: Scott Bolesta, PharmD, BCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Marc M Perreault, MSc, PharmD
role: STUDY_DIRECTOR
affiliation: MOUNT SINAI HOSPITAL
name: Lisa Burry, PharmD
role: STUDY_DIRECTOR
affiliation: The University of Arizona College of Pharmacy
name: Brian L Erstad, PharmD, MCCM
role: STUDY_DIRECTOR
affiliation: Ingram School of Nursing
name: Céline Gélinas, N., Ph.D.
role: STUDY_DIRECTOR
affiliation: Tufts University School of Medicine
name: Richard R Riker, MD, FCCM
role: STUDY_DIRECTOR
affiliation: Wilkes University
name: Katrianna D Saltarelli, Student
role: STUDY_CHAIR
affiliation: Wilkes University
name: Jennifer Mitchell, Student
role: STUDY_CHAIR
affiliation: MaineHealth
name: Kathryn E Smith, PharmD, BCPS, BCCCP
role: STUDY_DIRECTOR
affiliation: Hospital Italiano de Buenos Aires
name: Federico Carini, MD
role: STUDY_DIRECTOR
affiliation: Ulster Hospital- South Eastern Health and Social Care Board
name: Rebekah Eadie, MPharm, MSc, IP, MPSNI
role: STUDY_DIRECTOR
affiliation: Wilkes University
name: Jamie Harpel, Student
role: STUDY_CHAIR
affiliation: Wilkes University
name: Ryan Stewart, Student
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.
citation: 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.
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citation: 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.
citation: 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.
citation: 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.