Trial intelligence / Profile preview

Clonidine vs. Dexmedetomidine in Agitated Delirium

NCT04758936Phase 4

Key facts

Status
Unknown
Start
Feb 2021
Primary completion
Feb 2022
Countries
1
Sponsor
Erasmus Hospital
Modality
Small Molecules
Conditions
delirium
01

Overview

Phase 4, randomised, open-label trial in delirium comparing Clonidine Arm with Dexmedetomidine Arm (2 arms). Primary endpoint: Hemodynamic tolerance at 7 days. Status: unknown.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Clonidine Arm

    Clonidine infusion titrated based on sedation and analgesia scales.

  • Dexmedetomidine Arm

    Dexmedetomidine infusion titrated based on sedation and analgesia scales.

03

Who it enrols

Patients with agitated delirium confirmed by CAM-ICU requiring mechanical restraint or sedation, excluding those with severe organ failure, neurological issues, or hemodynamic instability.

04

Endpoints

Primary

  • Hemodynamic tolerance

Secondary

  • Number of living days without ventilation over 28 days

  • Time to obtain a sedative sedation score (NICS -1 to 1)

  • Time to obtain a first CAM-ICU test indicating the absence of delirium

  • Duration of delirium by evaluation CAM-ICU

  • Use of other sedative and psychotropic medications

  • Number of catheters / agitation extubation

  • Number of patients with tracheostomy

  • Daily assessment of organ dysfunction by SOFA score

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