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RecruitingNCT07316894Updated Jan 5, 2026

IWS Diagnosis Criteria Consensus

An observational study in Iatrogenic Withdrawal Syndrome, sponsored by ELIAS Emergency University Hospital. Recruiting at 1 site in Romania. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by ELIAS Emergency University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Dec 2025; still recruiting 9 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
120
Sex
All
01

Study summary

This is an International Delphi Consensus on the Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in adult critically ill patients. It involves the anonymous completion of a questionnaire using a 7-point Likert scale.

02

Conditions studied

  • Iatrogenic Withdrawal Syndrome

Keywords

  • iatrogenicwithdrawalsyndrome
  • ICU
  • delphiconsensus
03

In context

Lead sponsor

ELIAS Emergency University Hospital is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Professionals from the following medical specialties are eligible: Intensive Care Medicine, Anesthesiology or Psychiatry.

Participants to this Delphi Consensus must have at least 5 years of experience in their field.

Academic title or previous research published in the field of Iatrogenic Withdrawal Syndrome are not mandatory.

Inclusion criteria

  • At least 5 years of experience or training or research in the field of Intensive Care Medicine, Anesthesiology or Psychiatry

Exclusion criteria

Exclusion Criteria:

  • Not a specialist in the fields of Intensive Care Medicine, Anesthesiology or Psychiatry
05

Study design

Observational model
Other
Time perspective
Other
Enrollment
120 participants (estimated)
Patient registry
No

Interventions

  • OtherICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS.

    This is a new and originally developed questionnaire comprising of 19 questions. Out of 19 questions, 17 use a 7-point Likert scale response, one uses a Yes/No type of answer and one has open answers.

06

What researchers measure

Primary outcomes

  1. Diagnostic Criteria of IWS

    The diagnostic criteria of IWS will be determined based on the items reaching the consensus

    Time frame: 4 monts

07

Study locations

1 of 1 sites recruiting
  • Elias Emergency University Hospital
    Bucharest, 011461, Romania
    • Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC · Contact · emanuel.moisa@umfcd.ro · +40753021128
    • Georgeana Tuculeanu, Assist. Prof., MD · Contact · georgeana.tuculeanu@gmail.com · +40751141239
    • Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC · Principal investigator
    Recruiting
08

References and documents

Publications

  • Moisa E, Tuculeanu G, Corneci D, Negoita SI, Bilotta F. Iatrogenic withdrawal syndrome in adult intensive care unit: a scoping review. Front Med (Lausanne). 2025 Jul 23;12:1573363. doi: 10.3389/fmed.2025.1573363. eCollection 2025. PubMed 40771468 ↗

Individual participant data

Plan to share: Yes — The exact number of answers provided for each question from the questionnaire will be provided, as well as all the Delphi rounds in which agreement was or was not met. Demographic data about experts in order to ensure their eligibility.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07316894
Lead sponsor
ELIAS Emergency University Hospital
Collaborators
University of Rome Tor Vergata, Boston University, Carol Davila University of Medicine and Pharmacy
Responsible party
Emanuel Moisa (MD, PhD, DESAIC, Assistant Professor and Specialist of Anaesthesia and Critical Care Medicine,, ELIAS Emergency University Hospital) — Principal investigator
First posted
Jan 5, 2026
Start date
Dec 13, 2025
Primary completion
Mar 31, 2026 (estimated)
Completion
May 1, 2026 (estimated)
Last update
Jan 5, 2026

Study contacts

Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC
Contact
emanuel.moisa@umfcd.ro
+40753021128
Jamel Ortoleva, Assoc. Prof, MD, FASE
Contact
812-272-7078
Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC
principal investigator · Elias Emergency University Hospital of Bucharest, Carol Davila University of Medicine and Pharmacy, Bucharest
Federico Bilotta, Professor, MD, PhD
study chair · Tor Vergata University of Rome

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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