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Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients

NCT04758936 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2021-02-17

No results posted yet for this study

Summary

Delirium is one of the most common manifestations of cerebral dysfunction in severely ill patients.

The international guidelines for the prevention of delirium in intensive care recommend the daily application of environmental, behavioral and pharmacological strategies. In the case of the agitated form of delirium, experts recommend the use of low-dose neuroleptics and α-2 agonists to control psychotic manifestations rather than traditional sedatives (mainly benzodiazepines) that can clearly aggravate delirium.

Currently, two pharmacological α-2 agonists, clonidine (Catapressan®, Boehringer Ingelheim) and dexmedetomidine (Dexdor®, Orion Corporation), are marketed and commonly used in intensive care for their sedative, anxiolytic and analgesic properties.

To our knowledge, no studies have compared the effects of clonidine and dexmedetomidine in agitated delirium in intensive care patients. Therefore, our goal is to compare the safety of clonidine and dexmedetomidine (in terms of bradycardia and / or hypotension) in addition to standard treatment in the context of agitated delirium in intensive care patients.

Conditions

  • Delirium
  • Critical Illness

Interventions

DRUG

Clonidine

The doses administered (clonidine 1500mg diluted in NaCl0.9% solution of 50 ml) ranged from 0.01μg/kg/min to 0.03μg/kg/min.

DRUG

Dexmedetomidine

The doses administered (dexmedetomidine 200mg diluted in NaCl0.9% 50ml) ranged from 0.4μg/kg/h and can be titrated up to 1.4μg/kg/h.

Sponsors & Collaborators

  • Erasme University Hospital

    lead OTHER

Principal Investigators

  • Creteur Jacques, MD PhD · CUB Erasme Hospital ULB

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-01
Primary Completion
2022-02-28
Completion
2023-02-28

Countries

  • Belgium

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 NCT04758936 on ClinicalTrials.gov