AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU)
- Conditions
- Withdrawal SyndromeIatrogenic Disease
- Registration Number
- NCT04422808
- Lead Sponsor
- Wilkes University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2437
- 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.
- Patients who have not received parenteral analgesics or sedatives in the previous 24 hours.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number patients weaned from parenteral analgesics Three months 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.
- Secondary Outcome Measures
Name Time Method Patient proportion Three months Proportion of ICU patients who are receiving continuous analgesics and sedatives
Number of patients assessed three months Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.
Assessment tools three months Assessment tools being utilized for iatrogenic withdrawal.
Standardized approach patients three months Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.
Utilized analgesic and sedative weaning practice three months Types of analgesic and sedative weaning practices being utilized in adult ICU patients.
Trial Locations
- Locations (1)
Wilkes University
🇺🇸Wilkes-Barre, Pennsylvania, United States