Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients

• Status: Recruiting
• Trial end date: 2023-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Erasme University Hospital
• Treatments: Clonidine; Dexmedetomidine

Criteria

Inclusion Criteria:

• present agitated delirium, confirmed by the CAM-ICU diagnostic scale

• require mechanical restraint or psychotropic / sedative

Exclusion Criteria:

• Acute neurological central or medullary problems (vascular, traumatic, infectious, tumoral causes)

• Severe hepatic insufficiency (Child C cirrhosis)

• Severe renal insufficiency (creatinine clearance <30ml / min) or renal replacement therapy

• Bradycardia <60 / min

• 2nd or 3rd degree atrioventricular block (unless placed pacemaker)

• Hemodynamic instability (MAP <60mmHg despite adequate vascular filling and vasopressor treatment).

• Pregnant woman or breastfeeding

• Use of α-2 agonist or antagonist agents within 24 hours of randomization

• Allergy known to one of the α-2 agonists used in the study

• Moribund patient (survival prognosis at limited 24h or therapeutic de-escalation envisaged)