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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Withdrawal Syndrome, Iatrogenic Disease

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid withdrawal, Benzodiazepine withdrawal, Narcotic withdrawal, Critically ill