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

Withdrawal Syndrome Clinical Trial

Official title:

Assessing Current Analgesia and Sedation Weaning Practices in Adult Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422808
• Other study ID #: 116
• Status: Completed
• Start date: June 1, 2021
• Est. completion date: April 1, 2022

Study information

• Verified date: July 2022
• Source: Wilkes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2437
• Est. completion date: April 1, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Iatrogenic Disease
• Substance Withdrawal Syndrome
• Withdrawal Syndrome

Locations

Country	Name	City	State
United States	Wilkes University	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Wilkes University

Country where clinical trial is conducted

United States, 

References & Publications (8)

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. do — View 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. — View 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. — View 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: 10.1177/106002801772453 — View Citation

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 — View Citation

Duceppe MA, Perreault MM, Frenette AJ, Burry LD, Rico P, Lavoie A, Gélinas 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 — View Citation

Fonsmark L, Rasmussen YH, Carl P. Occurrence of withdrawal in critically ill sedated children. Crit Care Med. 1999 Jan;27(1):196-9. — View Citation

Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gélinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observatio — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Patient proportion	Proportion of ICU patients who are receiving continuous analgesics and sedatives	Three months
Secondary	Utilized analgesic and sedative weaning practice	Types of analgesic and sedative weaning practices being utilized in adult ICU patients.	three months
Secondary	Number of patients assessed	Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.	three months
Secondary	Assessment tools	Assessment tools being utilized for iatrogenic withdrawal.	three months
Secondary	Standardized approach patients	Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.	three months