Iatrogenic Withdrawal SyndromeNCT07316894
IWS Diagnosis Criteria Consensus
An observational study of Iatrogenic Withdrawal Syndrome, run by ELIAS Emergency University Hospital at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Iatrogenic Withdrawal Syndrome
- What is being tested?
- ICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS.
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- 13 Dec 2025to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- At least 5 years of experience or training or research in the field of Intensive Care Medicine, Anesthesiology or Psychiatry
Who cannot join
- Not a specialist in the fields of Intensive Care Medicine, Anesthesiology or Psychiatry
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jamel Ortoleva, Assoc. Prof, MD, FASE contact
Romania1 site, 1 recruiting
- Recruiting
Elias Emergency University Hospital
Bucharest, 011461
Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC, +40753021128, emanuel.moisa@umfcd.ro
Georgeana Tuculeanu, Assist. Prof., MD, +40751141239, georgeana.tuculeanu@gmail.com
About this study
Official title: 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.
- Conditions
- Iatrogenic Withdrawal Syndrome
- Being tested
- ICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS.
- Keywords
- iatrogenicwithdrawalsyndrome, ICU, delphiconsensus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU, Anesthesiology and Psychiatry specialists consensus on the diagnosis of IWS.Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Criteria of IWS
The diagnostic criteria of IWS will be determined based on the items reaching the consensus
Measured: 4 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start13 Dec 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Iatrogenic Withdrawal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ELIAS Emergency University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Rome Tor Vergata, Boston University, Carol Davila University of Medicine and Pharmacy
- Responsible party
- Principal investigator, Emanuel Moisa, ELIAS Emergency University Hospital
- Investigators
- Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC, Principal investigator, Elias Emergency University Hospital of Bucharest, Carol Davila University of Medicine and Pharmacy, BucharestFederico Bilotta, Professor, MD, PhD, Study chair, Tor Vergata University of Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316894
- Sponsor's protocol ID
- 10122025
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Delphi Consensus on the Universal Definition and Diagnosis of Iatrogenic Withdrawal Syndrome in Adult ICU Patients
- ClinicalTrials.gov ID
- NCT07316894
- Acronym / sponsor ID
- 10122025
- Conditions
- Iatrogenic Withdrawal Syndrome
- Keywords
- iatrogenicwithdrawalsyndrome, ICU, delphiconsensus
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- ELIAS Emergency University HospitalUniversity, hospital or other
- Collaborators
- University of Rome Tor Vergata, Boston University, Carol Davila University of Medicine and Pharmacy
- Study start
- 13 Dec 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- At least 5 years of experience or training or research in the field of Intensive Care Medicine, Anesthesiology or Psychiatry
Key exclusion criteria (1 listed)
- Not a specialist in the fields of Intensive Care Medicine, Anesthesiology or Psychiatry
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICU, 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. | Other | – |
Primary outcome
Diagnostic Criteria of IWS
Time frame: 4 monts
The diagnostic criteria of IWS will be determined based on the items reaching the consensus
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Background: PubMed 40771468Moisa 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.
- Individual participant dataSharing planned: 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jamel Ortoleva, Assoc. Prof, MD, FASE contact
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iatrogenic Withdrawal Syndrome, run by ELIAS Emergency University Hospital at 1 site in Romania.
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: looking for participants now, as of the sponsor's last update on 5 Jan 2026. 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 Romania. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emanuel Moisa, Assist. Prof., MD, PhD, DESAIC (+40753021128, emanuel.moisa@umfcd.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Criteria of IWS (time frame: 4 monts). 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 NCT07316894, which also lists 1 linked publication.
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 5 Jan 2026.