A Phase 3 interventional study of Dexmedetomidine and Placebo in Delirium and Agitation, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-13.
Sponsored by University Hospital, Clermont-Ferrand · Phase 3, Interventional, and Treatment
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Among 78 studies testing dexmedetomidine in Delirium — 16 open to participants now, 18 under way, 4 of them phase 3. Dexmedetomidine · Delirium.
Among the 78 studies testing dexmedetomidine in Delirium, this one is the 31st largest by enrollment, is one of 5 that started in 2017, is one of 11 in phase 3, and was the 36th registered.
933 studies on the registry are indexed under Delirium; 189 are open to participants now.
Browse Delirium studies →16 of the 78 studies testing dexmedetomidine in Delirium are open now, in 6 countries. Recruiting first, the newest first:
Massachusetts General Hospital · Sites in United States
Ages 60+
Bruyere Research Institute · Sites in Canada
Ages 18+
Tanta University · Sites in Egypt
Ages 21+
Tanta University · Sites in Egypt
Ages 65+
Beijing Tiantan Hospital · Sites in China
Ages 18+
By country, each count listing its studies:
Dexmedetomidine: first FDA approval 1999 (PRECEDEX), first EMA approval 2011. What it is approved for, and how studies give it, is on its page →
Of the 127 Delirium studies recruiting now, 99 (78%) set no upper age limit and 8 (6%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
78 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 10 · Phase 3 12 · Phase 4 35
First in 2004; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 168 is above the median of 112 across 550 interventional studies indexed under Delirium.
Median enrollment 98 across the 78 interventional studies. Of the 36 that completed or were terminated, 8 (22%) have results posted.
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4 of 78 have an industry lead sponsor. The 10 most frequent:
University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.
University Hospital, Clermont-Ferrand has 4 studies filed under Delirium — fewer than ten, so there is no comparison to draw.
3 of the studies testing dexmedetomidine in Delirium that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06192615Phase 3Massachusetts General HospitalMinimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II) | 2027-10-31 |
| NCT04669457University of Massachusetts, WorcesterPediatric Delirium | 2027-04-05 |
| NCT07781462Alexandria UniversityIntravenous Infusion of Low Dose Ketamine Versus Dexmedetomedine for Delirium Treatment in Acute Heart Failure | 2027-09 |
Add all 3 to your calendar (.ics) → With an account.
Among the 78 studies testing dexmedetomidine in Delirium, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients
Delirium during intensive care unit (ICU) stay is frequent and associated with significant morbidity, mortality and healthcare related costs. International guidelines suggest its prevention. However, curative treatment remains unclearly established. Despite a non-unequivocal literature, haloperidol is the first line recommended neuroleptic. Dexmedetomidine, an alpha2-adrenergic receptors agonist has shown its efficiency in the treatment of delirium in intubated patients but also in its prevention. Dexmedetomidine represents a widely used alternative to haloperidol. Only few studies have compared the efficacy of dexmedetomidine in non-intubated ICU patients as a first line curative treatment of delirium. Main objective of 4D trial is to demonstrate that dexmedetomidine decreases delirium duration compared to placebo.
The 4D trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 300 non-intubated ICU patients with diagnosis of agitated delirium to receive dexmedetomidine or placebo as a cure. The primary outcome measure is a composite of duration of agitation or delirium or the use of intubation with deep sedation and mechanical ventilation. Secondary outcomes include mortalities at 7 and 28 days, ICU length of stay and occurrence of adverse effects. The sample size will allow the detection of a 50% decrease of agitation duration (120 minutes), of an absolute reduction of delirium duration (1 day) and of a 50% relative decrease of intubation and mechanical ventilation, with a type 1 error rate of 1.8 % (error risk inflation due to components of composite) and power of 90 %, assuming a 15 % incidence of intubation and mechanical ventilation requirements, an agitation duration of 240 minutes and a delirium duration of 3 days. One hundred and 10 patients by group will be needed. A intermediate analysis is scheduled and requires the inclusion of 150 patients in each group.
The 4D trial may provide important data on the safety of commonly used sedative dexmedetomidine and could have a significant impact on future treatment of non-intubated ICU patients presenting with agitated delirium.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age > 18 years
Exclusion Criteria:
Age \<18 years
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in the Dexmedetomidine (interventional) group will be treated with a continuous infusion of dexmedetomidine in case of agitated delirium.
Drug: Dexmedetomidine
Patients in the Normal Saline (control) group will be treated with a continuous infusion of normal saline in case of agitated delirium.
Other: Placebo
The 4D trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 300 non-intubated ICU patients with diagnosis of agitated delirium to receive dexmedetomidine or placebo as a cure
The 4D trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 300 non-intubated ICU patients with diagnosis of agitated delirium to receive dexmedetomidine or placebo as a cure
Duration of Agitation (in Hours), Defined by a RASS ≥ +1
Time frame: at day 1
Duration of Delirium (in Days), Defined by a Positive CAM-ICU
Time frame: Day 30
Requirement of Intubation
requirement of intubation to control delirium with deep sedation and mechanical ventilation
Time frame: at day 1
Length of ICU Stay (in Days)
Time frame: day 30
Number of Ventilator Free Days
Time frame: at day 30
Adverse Effects Such as the Occurence of Pneumonia (Following the ATS Definitions) and/or Septicemia
Time frame: at day 30
Occurrence of Hypotension Requiring Any Vasopressor Administration and / or Tachycardia
Time frame: at day 30
All-cause Mortality
Time frame: at day 30
All-cause Mortality
Time frame: at day 7
Patients were enrolled at 9 centers between December 2017 and February 2022.
| Milestone | Dexmedetomidine | Placebo |
|---|---|---|
| Started | 84 | 84 |
| Completed | 77 | 74 |
| Not completed | 7 | 10 |
| Withdrew: Withdrawal by subject | 7 | 10 |
| hours | Dexmedetomidine | Placebo |
|---|---|---|
| Duration of Agitation (in Hours), Defined by a RASS ≥ +1 | 1 (1 to 2) | 2 (1 to 7) |
| Days | Dexmedetomidine | Placebo |
|---|---|---|
| Duration of Delirium (in Days), Defined by a Positive CAM-ICU | 0.8 (0.5 to 1.3) | 1 (0.5 to 1.7) |
requirement of intubation to control delirium with deep sedation and mechanical ventilation
| Participants | Dexmedetomidine | Placebo |
|---|---|---|
| Requirement of Intubation | 2 | 3 |
| Days | Dexmedetomidine | Placebo |
|---|---|---|
| Length of ICU Stay (in Days) | 13 (7 to 21) | 12 (8 to 19) |
| Days | Dexmedetomidine | Placebo |
|---|---|---|
| Number of Ventilator Free Days | 7 (2 to 13) | 6 (3 to 7) |
| Occurrences | Dexmedetomidine | Placebo |
|---|---|---|
| Adverse Effects Such as the Occurence of Pneumonia (Following the ATS Definitions) and/or Septicemia | 7 (2 to 21) | 6 (3 to 19) |
| Participants | Dexmedetomidine | Placebo |
|---|---|---|
| Occurrence of Hypotension Requiring Any Vasopressor Administration and / or Tachycardia | 34 | 25 |
| Participants | Dexmedetomidine | Placebo |
|---|---|---|
| All-cause Mortality | 10 | 13 |
| Participants | Dexmedetomidine | Placebo |
|---|---|---|
| All-cause Mortality | 6 | 5 |
Collected over Day 30. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Dexmedetomidine | 10/77 (13%) | 0/77 (0%) | 52/77 (67.5%) |
| Placebo | 13/74 (17.6%) | 0/74 (0%) | 41/74 (55.4%) |
| Event | Dexmedetomidine | Placebo |
|---|---|---|
| HypotensionBlood and lymphatic system disorders | 52/77 | 41/74 |
| Age, Continuous(years) | Dexmedetomidine | Normal Saline (NaCl 0.9%) | Total |
|---|---|---|---|
| Median | 69 (63 to 77) | 72 (64 to 77) | 70 (63 to 77) |
| Sex: Female, Male(Participants) | Dexmedetomidine | Normal Saline (NaCl 0.9%) | Total |
|---|---|---|---|
| Female | 14 | 18 | 32 |
| Male | 63 | 56 | 119 |
| Ethnicity (NIH/OMB)(Participants) | Dexmedetomidine | Normal Saline (NaCl 0.9%) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 0 | 0 |
| Unknown or Not Reported | 77 | 74 | 151 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in May 2021, 41 months.
Results were first posted in May 2026, 4 years 11 months after primary completion.
Of 27 phase 3 interventional studies under Delirium, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 59. This study's 41 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexmedetomidine
University Hospital, Clermont-Ferrand →