Clinical trial

The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients CATAPRES (Confusion and Alpha-Two Agonist Prescription Randomised Efficacy Study)

Name

Cat1.1

Description

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.

Trial arms

Trial start

2024-01-01

Estimated PCD

2024-12-01

Trial end

2025-06-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Clonidine

o The concentration of clonidine in the solution is 12.5 µg/ml. Continuous iv infusion of 0.02 ml/kg/h results in a dosage of 0.25 µg/kg/h. The maximum dosage achieved is 25 µg/h. The total amount of clonidine given to a person with a body weight 100 kg or more will be 600 µg a day. Since the doses chosen are in the low range, there will be no dosage adjustment for renal- or liver failure.

Arms:

Clonidine

Other names:

Catapressan

SodiumChloride

Placebo. Pharmaceutical form: Injection. Route of administration: Intravenous use.

Arms:

Sodium chloride

Other names:

Placebo

Size

115

Primary endpoint

CAM-ICU (Confusion Assessment Method for the Intesive Care Unit)

7 days

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 115, 'type': 'ESTIMATED'}}

Updated at

2023-02-15

1 organization

2 products

1 indication

Organization

Product

Indication

Product