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Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)

NCT03317067 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-05-13

Study results available
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Summary

The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients

Conditions

  • Delirium
  • Agitation

Interventions

DRUG

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

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

Sponsors & Collaborators

  • University Hospital, Clermont-Ferrand

    lead OTHER

Principal Investigators

  • Thomas GODET · University Hospital, Clermont-Ferrand

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-21
Primary Completion
2021-05-21
Completion
2023-02-23

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03317067 on ClinicalTrials.gov