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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Three months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient proportion | Proportion of ICU patients who are receiving continuous analgesics and sedatives | Three months |
| Utilized analgesic and sedative weaning practice | Types of analgesic and sedative weaning practices being utilized in adult ICU patients. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Gilles L Fraser, PharmD, MCCM | Tufts University School of Medicine | Study Director |
| Scott Bolesta, PharmD, BCPS | Wilkes University | Principal Investigator |
| 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 Director |
| Katrianna D Saltarelli, Student | Wilkes University | Study Chair |
| Jennifer Mitchell, Student | Wilkes University | Study Chair |
| Kathryn E Smith, PharmD, BCPS, BCCCP |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wilkes University | Wilkes-Barre | Pennsylvania | 18701-1013 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29292273 | Result | Borkowska M, Labeau S, Schepens T, Vandijck D, Van de Vyver K, Christiaens D, Lizy C, Blackwood B, Blot SI. Nurses' Sedation Practices During Weaning of Adults From Mechanical Ventilation in an Intensive Care Unit. Am J Crit Care. 2018 Jan;27(1):32-42. doi: 10.4037/ajcc2018959. | |
| 10776874 | Result | Brown C, Albrecht R, Pettit H, McFadden T, Schermer C. Opioid and benzodiazepine withdrawal syndrome in adult burn patients. Am Surg. 2000 Apr;66(4):367-70; discussion 370-1. |
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Plan is to share individual participant data specific to each institution through data access groups in RedCap
Twelve months after data collection completed.
Individual site data will be accessible to each specific participating study site. Only site investigators will have access to their study site data.
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| ID | Term |
|---|---|
| D013375 | Substance Withdrawal Syndrome |
| D007049 | Iatrogenic Disease |
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
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| three months |
| Number of patients assessed | Number of patients being assessed for iatrogenic withdrawal after receiving continuous analgesics and sedatives. | three months |
| Assessment tools | Assessment tools being utilized for iatrogenic withdrawal. | three months |
| Standardized approach patients | Number of patients in which a standardized approach to iatrogenic withdrawal assessment is being utilized. | three months |
| 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 Director |
| Jamie Harpel, Student | Wilkes University | Study Chair |
| Ryan Stewart, Student | Wilkes University | Study Chair |
| 9559604 | Result | Cammarano WB, Pittet JF, Weitz S, Schlobohm RM, Marks JD. Acute withdrawal syndrome related to the administration of analgesic and sedative medications in adult intensive care unit patients. Crit Care Med. 1998 Apr;26(4):676-84. doi: 10.1097/00003246-199804000-00015. |
| 28793780 | Result | Chiu AW, Contreras S, Mehta S, Korman J, Perreault MM, Williamson DR, Burry LD. Iatrogenic Opioid Withdrawal in Critically Ill Patients: A Review of Assessment Tools and Management. Ann Pharmacother. 2017 Dec;51(12):1099-1111. doi: 10.1177/1060028017724538. Epub 2017 Aug 9. |
| 25602358 | Result | Curley MA, Wypij D, Watson RS, Grant MJ, Asaro LA, Cheifetz IM, Dodson BL, Franck LS, Gedeit RG, Angus DC, Matthay MA; RESTORE Study Investigators and the Pediatric Acute Lung Injury and Sepsis Investigators Network. Protocolized sedation vs usual care in pediatric patients mechanically ventilated for acute respiratory failure: a randomized clinical trial. JAMA. 2015 Jan 27;313(4):379-89. doi: 10.1001/jama.2014.18399. |
| 30569508 | Result | Duceppe MA, Perreault MM, Frenette AJ, Burry LD, Rico P, Lavoie A, Gelinas C, Mehta S, Dagenais M, Williamson DR. Frequency, risk factors and symptomatology of iatrogenic withdrawal from opioids and benzodiazepines in critically Ill neonates, children and adults: A systematic review of clinical studies. J Clin Pharm Ther. 2019 Apr;44(2):148-156. doi: 10.1111/jcpt.12787. Epub 2018 Dec 19. |
| 9934916 | Result | Fonsmark L, Rasmussen YH, Carl P. Occurrence of withdrawal in critically ill sedated children. Crit Care Med. 1999 Jan;27(1):196-9. doi: 10.1097/00003246-199901000-00052. |
| 28866754 | Result | Wang PP, Huang E, Feng X, Bray CA, Perreault MM, Rico P, Bellemare P, Murgoi P, Gelinas C, Lecavalier A, Jayaraman D, Frenette AJ, Williamson D. Opioid-associated iatrogenic withdrawal in critically ill adult patients: a multicenter prospective observational study. Ann Intensive Care. 2017 Sep 2;7(1):88. doi: 10.1186/s13613-017-0310-5. |
| 37283558 | Derived | Bolesta S, Burry L, Perreault MM, Gelinas C, Smith KE, Eadie R, Carini FC, Saltarelli K, Mitchell J, Harpel J, Stewart R, Riker RR, Fraser GL, Erstad BL; AduLt iatrogEnic withdRawal sTudy in the ICU (ALERT-ICU) Study Investigators. International Analgesia and Sedation Weaning and Withdrawal Practices in Critically Ill Adults: The Adult Iatrogenic Withdrawal Study in the ICU. Crit Care Med. 2023 Nov 1;51(11):1502-1514. doi: 10.1097/CCM.0000000000005951. Epub 2023 Jun 7. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |