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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04422808
Enrollment
2437
Registered
2020-06-09
Start date
2021-06-01
Completion date
2022-04-01
Last updated
2022-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Iatrogenic Disease, Withdrawal Syndrome

Keywords

Opioid withdrawal, Benzodiazepine withdrawal, Narcotic withdrawal, Critically ill

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.

Interventions

None listed

Sponsors

Wilkes University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number patients weaned from parenteral analgesicsThree monthsThe 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

MeasureTime frameDescription
Assessment toolsthree monthsAssessment tools being utilized for iatrogenic withdrawal.
Standardized approach patientsthree monthsNumber of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.
Patient proportionThree monthsProportion of ICU patients who are receiving continuous analgesics and sedatives
Utilized analgesic and sedative weaning practicethree monthsTypes of analgesic and sedative weaning practices being utilized in adult ICU patients.
Number of patients assessedthree monthsNumber of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026