Trial Outcomes & Findings for Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial) (NCT NCT03317067)
NCT ID: NCT03317067
Last Updated: 2026-05-13
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
168 participants
Primary outcome timeframe
at day 1
Results posted on
2026-05-13
Participant Flow
Patients were enrolled at 9 centers between December 2017 and February 2022.
Patients who had been admitted to a participating ICU were eligible for enrollment if they were 18 years of age or older, were not receiving invasive mechanical ventilation, had a Richmond agitation sedation scale (RASS) score \[18\] of + 1 or higher, and had received a positive result on the screening test for delirium according to the Confusion Assessment Method for the ICU (CAM-ICU)
Participant milestones
| Measure |
Dexmedetomidine
In this group patients were assigned to receive dexmedetomidine
|
Placebo
In this group patients were assigned to receive placebo
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
84
|
|
Overall Study
COMPLETED
|
77
|
74
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
Reasons for withdrawal
| Measure |
Dexmedetomidine
In this group patients were assigned to receive dexmedetomidine
|
Placebo
In this group patients were assigned to receive placebo
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
10
|
Baseline Characteristics
Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)
Baseline characteristics by cohort
| Measure |
Dexmedetomidine
n=77 Participants
Patients in the Dexmedetomidine (interventional) group will be treated with a continuous infusion of dexmedetomidine in case of agitated delirium.
Dexmedetomidine: 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
|
Normal Saline (NaCl 0.9%)
n=74 Participants
Patients in the Normal Saline (control) group will be treated with a continuous infusion of normal saline in case of agitated delirium.
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
|
Total
n=151 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
63 Participants
n=1512 Participants
|
56 Participants
n=504 Participants
|
119 Participants
n=2016 Participants
|
|
Age, Continuous
|
69 years
n=1512 Participants
|
72 years
n=504 Participants
|
70 years
n=2016 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=1512 Participants
|
18 Participants
n=504 Participants
|
32 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=1512 Participants
|
0 Participants
n=504 Participants
|
0 Participants
n=2016 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
77 Participants
n=1512 Participants
|
74 Participants
n=504 Participants
|
151 Participants
n=2016 Participants
|
PRIMARY outcome
Timeframe: at day 1Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Duration of Agitation (in Hours), Defined by a RASS ≥ +1
|
1 hours
Interval 1.0 to 2.0
|
2 hours
Interval 1.0 to 7.0
|
PRIMARY outcome
Timeframe: Day 30Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Duration of Delirium (in Days), Defined by a Positive CAM-ICU
|
0.8 Days
Interval 0.5 to 1.3
|
1 Days
Interval 0.5 to 1.7
|
PRIMARY outcome
Timeframe: at day 1requirement of intubation to control delirium with deep sedation and mechanical ventilation
Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Requirement of Intubation
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: day 30Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Length of ICU Stay (in Days)
|
13 Days
Interval 7.0 to 21.0
|
12 Days
Interval 8.0 to 19.0
|
SECONDARY outcome
Timeframe: at day 30Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Number of Ventilator Free Days
|
7 Days
Interval 2.0 to 13.0
|
6 Days
Interval 3.0 to 7.0
|
SECONDARY outcome
Timeframe: at day 30Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Adverse Effects Such as the Occurence of Pneumonia (Following the ATS Definitions) and/or Septicemia
|
7 Occurrences
Interval 2.0 to 21.0
|
6 Occurrences
Interval 3.0 to 19.0
|
SECONDARY outcome
Timeframe: at day 30Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
Occurrence of Hypotension Requiring Any Vasopressor Administration and / or Tachycardia
|
34 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: at day 30Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
All-cause Mortality
|
10 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: at day 7Outcome measures
| Measure |
Dexmedetomidine
n=77 Participants
Patients were assigned to receive dexmedetomidine
|
Placebo
n=74 Participants
Patients were assigned to receive placebo -
|
|---|---|---|
|
All-cause Mortality
|
6 Participants
|
5 Participants
|
Adverse Events
Dexmedetomidine
Serious events: 0 serious events
Other events: 52 other events
Deaths: 10 deaths
Placebo
Serious events: 0 serious events
Other events: 41 other events
Deaths: 13 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dexmedetomidine
n=77 participants at risk
Patients were assigned to receive dexmedetomidine -
|
Placebo
n=74 participants at risk
Patients were assigned to receive placebo
|
|---|---|---|
|
Blood and lymphatic system disorders
Hypotension
|
67.5%
52/77 • Number of events 52 • Day 30
|
55.4%
41/74 • Number of events 41 • Day 30
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place