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

Sponsor

Wilkes University (Other)

Overall Status

Completed

CT.gov ID

NCT04422808

Collaborator

(none)

2,437

Enrollment

Location

Actual Duration (Months)

244

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Withdrawal Syndrome Iatrogenic Disease

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.

Study Design

Study Type:

Observational

Actual Enrollment :

2437 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Apr 1, 2022

Outcome Measures

Primary Outcome Measures

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

Patient proportion [Three months]
Proportion of ICU patients who are receiving continuous analgesics and sedatives
Utilized analgesic and sedative weaning practice [three months]
Types of analgesic and sedative weaning practices being utilized in adult ICU patients.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wilkes University	Wilkes-Barre	Pennsylvania	United States	18701-1013

Sponsors and Collaborators

Wilkes University

Investigators

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