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

July 28, 2022 updated by: Scott Bolesta, Pharm.D., BCPS, FCCM, FCCP, Wilkes University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

2437

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wilkes-Barre, Pennsylvania, United States, 18701-1013
        • Wilkes University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We anticipate the involvement of at least 50 intensive care unit centers within the United States, and less than 10 sites outside the United States (primarily in Canada, Australia, Europe, and the Middle East). Estimating an average of 10 patients who meet study criteria at each site.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number patients weaned from parenteral analgesics
Time Frame: 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.
Three months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

April 1, 2022

Study Registration Dates

First Submitted

June 4, 2020

First Submitted That Met QC Criteria

June 4, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

July 29, 2022

Last Update Submitted That Met QC Criteria

July 28, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 116

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Plan is to share individual participant data specific to each institution through data access groups in RedCap

IPD Sharing Time Frame

Twelve months after data collection completed.

IPD Sharing Access Criteria

Individual site data will be accessible to each specific participating study site. Only site investigators will have access to their study site data.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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