Pharmacokinetics and Clinical Effects of Escalating Doses of Clonidine in ICU Patients

NCT02466373 | Completed Phase 3 DMC

• 1 other identifier: Clonidine kinetics 1.1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This study is developed for assessing the pharmacodynamic and pharmacokinetic properties of intravenous (IV) clonidine in critically ill patients on the ICU, and to estimate the optimal dosing strategy for IV clonidine.

Conditions

Delirium; Critical Illness

Keywords

clonidine; pharmacodynamics; pharmacokinetics; intensive care; delirium

Outcome Measures

Primary Outcomes (1)

• clonidine plasma concentrations

  pharmacokinetic and pharmacodynamic properties of intravenous clonidine in ICU patients Clonidine plasma concentration at start of infusion at t=2, t=4, t=8 and t=12 h Clonidine plasma concentration during study, once daily Clonidine plasma concentration after stopping infusion at t=ω+8, t=ω+16, t=ω+24 h, and t=ω+48 h (ω= end of infusion).

  up to 7 days

Secondary Outcomes (4)

• heart rate

  up to 7 days

• blood pressure

  up to 7 days

• delirium

  up to 7 days

• use of antipsychotics

  up to 7 days

Study Arms (4)

No clonidine

NO INTERVENTION

No clonidine is administered. The outcome measures are recorded, to compare them with the outcome measures of the other clonidine arms

Clonidine 600mcg

EXPERIMENTAL

4 patients receive 600 µg/day of clonidine without loading schedule. 4 patients receive 600 µg/day of clonidine with a loading schedule of 300 µg in 4 h.

Drug: Clonidine (Catapresan®) 0,150 mg/ml, ampoule 1 ml

Clonidine 1200mcg

EXPERIMENTAL

* 4 patients receive 1200 µg/day of clonidine without loading schedule. * 4 patients receive 1200 µg/day of clonidine with a loading schedule of 600 µg in 4 h.

Drug: Clonidine (Catapresan®) 0,150 mg/ml, ampoule 1 ml

Clonidine 1800mcg

EXPERIMENTAL

* 4 patients receive 1800 µg/day of clonidine without loading schedule. * 4 patients receive 1800 µg/day of clonidine with a loading schedule of 900 µg in 4 h.

Drug: Clonidine (Catapresan®) 0,150 mg/ml, ampoule 1 ml

Interventions

Clonidine (Catapresan®) 0,150 mg/ml, ampoule 1 ml DRUG

clonidine intravenous

Also known as: Boehringer Ingelheim, RVG 06055

Clonidine 1200mcg; Clonidine 1800mcg; Clonidine 600mcg

Eligibility Criteria

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

You may qualify if:

• In order to be eligible to participate in this study, a subject must be:
• at least 18 years of age
• intubated
• sedated at the start of the study. Because of the high incidence of delirium on the ICU in all age categories, all age groups \> 18 years will be included

You may not qualify if:

• Severe neurotrauma,
• Severe dementia (living in a nursing home)
• Inability to speak Dutch or English, which is one of the causes of not being able to use the CAM-ICU.
• 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 vasopressors)
• Pregnancy and lactation (pregnancy test are routinely performed in premenopausal women on the ICU).
• Epilepsy
• Known clonidine intolerance
• Liver cirrhosis (Child Pugh class C)
• Recent and acute myocardial infarction
• Severe heart failure (LVEF \< 30%)
• Second or third degree atrioventricular (AV)-block without a permanent pacemaker
• Expected transfer to another hospital.

Sponsors & Collaborators

• Deventer Ziekenhuis: lead

Study Sites (1)

Deventer Hospital

Deventer, Netherlands

Location

MeSH Terms

Conditions

Delirium; Critical Illness

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; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

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

Study Officials

• Huub Oever v/d

  Deventer Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: drs M. Zeeman

Study Record Dates

• First Submitted: April 21, 2015
• First Posted: June 9, 2015
• Study Start: December 1, 2016
• Primary Completion: April 5, 2018
• Study Completion: April 5, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)