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Withdrawal SyndromeNCT04422808

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

An observational study of Withdrawal Syndrome and Iatrogenic Disease, run by Wilkes University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Withdrawal Syndrome, Iatrogenic Disease
How many people
2,437 participants
Where
1 siteUnited States
Study dates
1 Jun 2021to 1 Apr 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • Patients who have not received parenteral analgesics or sedatives in the previous 24 hours.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wilkes University

    Wilkes-Barre, Pennsylvania, 18701-1013

Other trials in United States

About this study

Official title: 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.

Read the 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.

Keywords
Opioid withdrawal, Benzodiazepine withdrawal, Narcotic withdrawal, Critically ill
Medical subject headings
Substance Withdrawal Syndrome, Iatrogenic Disease, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Three months

Secondary outcomes (5)

  1. Patient proportion

    Proportion of ICU patients who are receiving continuous analgesics and sedatives

    Measured: Three months

  2. Utilized analgesic and sedative weaning practice

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

    Measured: three months

  3. Number of patients assessed

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

    Measured: three months

  4. Assessment tools

    Assessment tools being utilized for iatrogenic withdrawal.

    Measured: three months

  5. Standardized approach patients

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

    Measured: three months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start1 Jun 2021
  3. Primary completion30 Sep 2021
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
2,437 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04422808
Sponsor's protocol ID
116
Status last verified
Jul 2022
First submitted
4 Jun 2020
Last updated
29 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Plan is to share individual participant data specific to each institution through data access groups in RedCap

Publications

  • 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.

    PubMed 29292273

  • 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.

    PubMed 10776874

  • 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.

    PubMed 9559604

  • 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.

    PubMed 28793780

  • 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.

    PubMed 25602358

  • 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.

    PubMed 30569508

  • 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.

    PubMed 9934916

  • 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.

    PubMed 28866754

  • 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.

    PubMed 37283558

Questions about this trial

What is this clinical trial studying?

An observational study of Withdrawal Syndrome and Iatrogenic Disease, run by Wilkes University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number patients weaned from parenteral analgesics (time frame: Three months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04422808, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022.

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