The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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 reduction of delirium. There are no large studies proving that this therapy is effective and safe.

Objective: The objective of this study is to compare the effect of clonidine with placebo on the occurrence and duration of delirium in mechanically ventilated ICU patients.

Study design: Prospective randomised double-blind placebo controlled intervention study in 115 patients.

Study population: All patients >18 years old, intubated mechanically ventilated and sedated at inclusion.

Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen. Comparison: NaCl 0,9 % infusion as placebo.

Main study parameters/endpoints: The main study parameter is the total number of awake and delirium-free observation periods the first 7 days after randomisation. An observation period is a nursing shift of 8 hours.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deventer Ziekenhuis
• Treatments: Clonidine

Criteria

Inclusion Criteria:

• Intubated and mechanically ventilated, at the start of the study medication.

• Age > 18 years

Exclusion Criteria:

• 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