IWS Diagnosis Criteria Consensus

December 19, 2025 updated by: Emanuel Moisa, ELIAS Emergency University Hospital

International Delphi Consensus on the Universal Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in Adult ICU Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC
  • Phone Number: +40753021128
  • Email: emanuel.moisa@umfcd.ro

Study Contact Backup

  • Name: Jamel Ortoleva, Assoc. Prof, MD, FASE
  • Phone Number: 812-272-7078

Study Locations

  • Romania
      • Bucharest, Romania, 011461
        • Recruiting
        • Elias Emergency University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Criteria of IWS
Time Frame: 4 monts
The diagnostic criteria of IWS will be determined based on the items reaching the consensus
4 monts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ELIAS Emergency University Hospital

Collaborators

Boston University
University of Rome Tor Vergata
Carol Davila University of Medicine and Pharmacy

Investigators

  • Principal Investigator: Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC, Elias Emergency University Hospital of Bucharest, Carol Davila University of Medicine and Pharmacy, Bucharest
  • Study Chair: Federico Bilotta, Professor, MD, PhD, Tor Vergata University of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2025

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

December 19, 2025

First Submitted That Met QC Criteria

December 19, 2025

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

December 19, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10122025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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