The effects and optimum dosing of clonidine in critically ill ventilated patients

Pharmacokinetics and clinical effects of escalating doses of clonidine in ICU patients - Clonidine kinetics 1.1

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001699-23-NL

Enrollment

Registered

2015-11-30

Start date

2015-12-01

Completion date

Unknown

Last updated

2018-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium The pharmacokinetic and dynamic properties of intravenous clonidine in critical ill mechanically treated patients

Interventions

Trade Name: Catapresan Product Name: Catapresan Pharmaceutical Form: Concentrate and solvent for solution for injection/infusion

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16

Exclusion criteria

Exclusion criteria: • 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 AV-block without a permanent pacemaker • Expected transfer to another hospital.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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 Hemodynamic parameters: Heart rate, blood pressure, 2-hrly for the first 12 h, 8-hrly thereafter. Laboratory parameters: Serum creatinine daily Albumin concentrations at study entry Clinical parameters: CAM-ICU delirium scale 8-hrly RASS sedation scale 8-hrly Need for fixation CVVH or dialysis Medication: Total amounts and average daily doses of: Noradrenalin, dobutamine, midazolam, morfine, propofol, haloperidol, other antipsychotics. Safety parameters: Adverse events Serious adverse events;Secondary Objective: Pharmacokinetic data: 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=?+8, t=?+16, t=?+24 h, and t=?+48 h (?= end of infusion).;Primary end point(s): Cessation of the need for sedative therapy;Timepoint(s) of evaluation of this end point: 7 Days or shorter	—

Measure

Time frame

Main Objective: 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 Hemodynamic parameters: Heart rate, blood pressure, 2-hrly for the first 12 h, 8-hrly thereafter. Laboratory parameters: Serum creatinine daily Albumin concentrations at study entry Clinical parameters: CAM-ICU delirium scale 8-hrly RASS sedation scale 8-hrly Need for fixation CVVH or dialysis Medication: Total amounts and average daily doses of: Noradrenalin, dobutamine, midazolam, morfine, propofol, haloperidol, other antipsychotics. Safety parameters: Adverse events Serious adverse events;Secondary Objective: Pharmacokinetic data: 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=?+8, t=?+16, t=?+24 h, and t=?+48 h (?= end of infusion).;Primary end point(s): Cessation of the need for sedative therapy;Timepoint(s) of evaluation of this end point: 7 Days or shorter

—

Secondary

Measure	Time frame
Secondary end point(s): Pharmacokinetic data;Timepoint(s) of evaluation of this end point: 7 days or shorter	—

Countries

Netherlands

Contacts

Public ContactM. Zeeman, investigator

Deventer Hospital

m.zeeman@dz.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026