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Completed

NCT Number: NCT04422808

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

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.

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Key information

Conditions

Withdrawal Syndrome Chemically-Induced Disorders Critical Illness Disease Attributes Iatrogenic Disease Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance Withdrawal Syndrome Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Wilkes University

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient proportion

    Time frame: Three months

    Proportion of ICU patients who are receiving continuous analgesics and sedatives

  2. Utilized analgesic and sedative weaning practice

    Time frame: three months

    Types of analgesic and sedative weaning practices being utilized in adult ICU patients.

  3. Number of patients assessed

    Time frame: three months

    Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.

  4. Assessment tools

    Time frame: three months

    Assessment tools being utilized for iatrogenic withdrawal.

  5. Standardized approach patients

    Time frame: three months

    Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.

Sponsors and collaborators

Lead sponsor

Wilkes University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Jul 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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