An observational study in Withdrawal Syndrome and Iatrogenic Disease, sponsored by Wilkes University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-29.
Sponsored by Wilkes University · Observational
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.
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.
39 studies on the registry are indexed under Iatrogenic Disease; 5 are open to participants now.
This study's enrollment of 2,437 is above the median of 582 across 16 observational studies indexed under Iatrogenic Disease.
Browse Iatrogenic Disease studies →Wilkes University is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Number patients weaned from parenteral analgesics
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.
Time frame: Three months
Patient proportion
Proportion of ICU patients who are receiving continuous analgesics and sedatives
Time frame: Three months
Utilized analgesic and sedative weaning practice
Types of analgesic and sedative weaning practices being utilized in adult ICU patients.
Time frame: three months
Number of patients assessed
Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives.
Time frame: three months
Assessment tools
Assessment tools being utilized for iatrogenic withdrawal.
Time frame: three months
Standardized approach patients
Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized.
Time frame: three months
Plan to share: Yes — Plan is to share individual participant data specific to each institution through data access groups in RedCap
Supporting information: Study protocol, Sap
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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