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

NCT01876355 | Unknown Phase 3 DMC

• 1 other identifier: Cat1.1
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Delirium

Keywords

Delirium, clonidine, ICU, sedation

Outcome Measures

Primary Outcomes (1)

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

  The total amount of delirium-free periods during 7 days after randomisation and start of the study medication. An observation period is a period of 8 hours, coinciding with one nursing shift. A delirium-free period is a shift in which the delirium score is negative.

  7 days

Secondary Outcomes (6)

• Signs of agitation

  7 days

• Opiate use

  7 days

• Sedative use

  7 days

• Anti-psychotic use

  7 days

• Ventilation free days

  7 days

Study Arms (2)

Clonidine

EXPERIMENTAL

Drug: Clonidine

Sodium chloride

PLACEBO COMPARATOR

Drug: SodiumChloride

Interventions

Clonidine DRUG

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.

Also known as: Catapressan

Clonidine

SodiumChloride DRUG

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

Also known as: Placebo

Sodium chloride

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Intubated and mechanically ventilated, at the start of the study medication.
• Age \> 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Deventer Ziekenhuis: lead

Study Sites (1)

Deventer Hospital

Deventer, Overijssel, 7416 SE, Netherlands

Location

MeSH Terms

Conditions

Delirium

Interventions

Clonidine

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazolines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• H.L.A. van den Oever

  Deventer Ziekenhuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Zeeman

CONTACT

+31570535045; M.Zeeman@dz.nl

H.L.A. van den Oever

CONTACT

+31570535353; OevervdH@dz.nl

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 10, 2013
• First Posted: June 12, 2013
• Study Start: January 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: February 15, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)