Phase 3
Completed N=168
Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
Delirium · Agitation
Source: ClinicalTrials.gov NCT03317067 ↗
Enrolled (actual)
168
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Duration of Agitation (in Hours), Defined by a RASS ≥ +1 — 1; 2 hours
◆ Published Evidence
Established
22citations · ~22 / year
Dexmedetomidine for treatment of hyperactive delirium in non-intubated ICU patients: the 4D randomized clinical trial.
Summary
The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients
Linked Publications (2)
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Dexmedetomidine for treatment of hyperactive delirium in non-intubated ICU patients: the 4D randomized clinical trial.
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Effects of dexmedetomidine on delirium duration of non-intubated ICU patients (4D trial): study protocol for a randomized trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Agitation (in Hours), Defined by a RASS ≥ +1 |
1; 2 | — |
| PRIMARY Duration of Delirium (in Days), Defined by a Positive CAM-ICU |
0.8; 1 | — |
| PRIMARY Requirement of Intubation |
2; 3 | — |
| SECONDARY Length of ICU Stay (in Days) |
13; 12 | — |
| SECONDARY Number of Ventilator Free Days |
7; 6 | — |
| SECONDARY Adverse Effects Such as the Occurence of Pneumonia (Following the ATS Definitions) and/or Septicemia |
7; 6 | — |
| SECONDARY Occurrence of Hypotension Requiring Any Vasopressor Administration and / or Tachycardia |
34; 25 | — |
| SECONDARY All-cause Mortality |
6; 5 | — |
Eligibility Criteria
Inclusion Criteria
- • Age > 18 years
- Patient hospitalized in an ICU
- Presenting a productive delirium according to the following criteria:
- acute onset ( +1
- Non-intubated or extubated (> 24h)
- No contraindication of dexmedetomidine or haloperidol uses
Exclusion Criteria
- • Age <18 years
- Administration of dexmedetomidine and/or clonidine during the 72 hours before inclusion
- Contraindication to the use of Dexmedetomidine, clonidine or haloperidol (history of allergy, Parkinson's disease, oro-pharyngeal dysfunction, arterial hypotension or bradycardia, QTc interval prolongation, and hepatic or renal dysfunction), as mentioned in the Summaries of Product Characteristics
- Neuropsychiatric pathology judged by the investigator as a potential source of bias (in particular: active drug addiction, psychosis...)
- Parturient or breast-feeding woman
- Protected major (guardianship)
- Patient's or relative's refusal to participate
Data sourced from ClinicalTrials.gov (NCT03317067) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.