Clinical trialNCT04422808CompletedObservational

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

SponsorWilkes UniversityEnrollment2,437Iatrogenic DiseaseWithdrawal Syndrome

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Brian L Erstad, PharmD, MCCM
The University of Arizona College of Pharmacy
Study Director
clinicaltrials.gov ↗
Céline Gélinas, N., Ph.D.
Ingram School of Nursing
Study Director
clinicaltrials.gov ↗
Federico Carini, MD
Hospital Italiano de Buenos Aires
Study Director
clinicaltrials.gov ↗
Gilles L Fraser, PharmD, MCCM
Tufts University School of Medicine
Study Director
clinicaltrials.gov ↗
Jamie Harpel, Student
Wilkes University
Study Chair
clinicaltrials.gov ↗
Jennifer Mitchell, Student
Wilkes University
Study Chair
clinicaltrials.gov ↗
Kathryn E Smith, PharmD, BCPS, BCCCP
MaineHealth
Study Director
clinicaltrials.gov ↗
Katrianna D Saltarelli, Student
Wilkes University
Study Chair
clinicaltrials.gov ↗
Lisa Burry, PharmD
MOUNT SINAI HOSPITAL
Study Director
clinicaltrials.gov ↗
Marc M Perreault, MSc, PharmD
Université de Montréal
Study Director
clinicaltrials.gov ↗
Rebekah Eadie, MPharm, MSc, IP, MPSNI
Ulster Hospital- South Eastern Health and Social Care Board
Study Director
clinicaltrials.gov ↗
Richard R Riker, MD, FCCM
Tufts University School of Medicine
Study Director
clinicaltrials.gov ↗
Ryan Stewart, Student
Wilkes University
Study Chair
clinicaltrials.gov ↗
Scott Bolesta, PharmD, BCPS
Wilkes University
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Wilkes University
Wilkes-Barre, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 1 Jun 2021
Primary completion: 30 Sept 2021
Completion: 1 Apr 2022
Last update posted: 29 Jul 2022
Registered enrollment: 2,437
Registry id: NCT04422808

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.