NCT04422808

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,437 (actual)
• Sponsor: Wilkes University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2021-06-01
• Primary completion: 2021-09-30
• Completion: 2022-04-01
• First posted: 2020-06-09
• Last updated: 2022-07-29

Locations

1 site across 1 country: United States