Status:
UNKNOWN
The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients
Lead Sponsor:
Deventer Ziekenhuis
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of GABA-ergic anaesthetics and...
Detailed Description
Rationale: Delirium is highly prevalent in the ICU. It may cause significant morbidity and mortality. One of the factors that may provoke a delirium is the use of GABA-ergic anaesthetics. Recent studi...
Eligibility Criteria
Inclusion
- Intubated and mechanically ventilated, at the start of the study medication.
- Age \> 18 years
Exclusion
- Severe neurotrauma/CVA
- Severe dementia
- Inability to speak Dutch or English
- The use of clonidine during the 96 hours before the start of the study.
- Bradycardia (\<50/min)
- Severe hypotension (MAP \< 65 after volume resuscitation and two vasopressors)
- Pregnancy
- Epilepsy
- Known clonidine intolerance
- Liver cirrhosis (Child-Pugh Class C)
- Recent and acute myocardial infarction
- Severe heart failure (LVEF\<30%)
- Second or third degree AV block
- Renal insufficiency requiring intermittent haemodialysis (CVVH is permitted)
- Expected transfer to another hospital
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT01876355
Start Date
January 1 2024
End Date
June 1 2025
Last Update
February 15 2023
Active Locations (1)
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1
Deventer Hospital
Deventer, Overijssel, Netherlands, 7416 SE