Pharmacokinetics of escalating doses of clonidine in ICU patients

Phase 3

Completed

Conditions: delirium
10012221

Registration Number: NL-OMON42780

Lead Sponsor: Deventer Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 32

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.

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
When renal failure (eGFR <30ml/min): maximum dose of clonidine will be 1200mcg

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic data:<br /><br>Clonidine plasma concentration at start of infusion at t=2, t=4, t=8 and t=12 h<br /><br>Clonidine plasma concentration during study, once daily<br /><br>Clonidine plasma concentration after stopping infusion at t=+8, t=+16, t=<br /><br>+24 h, and t=+48 h (*= end of infusion).<br /><br>clonidine concentrations in CVVH fluids</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Hemodynamic parameters:<br /><br>Heart rate, blood pressure, 2-hrly for the first 12 h, 8-hrly thereafter.<br /><br><br /><br>Laboratory parameters:<br /><br>Serum creatinine daily<br /><br>Albumin concentrations at study entry<br /><br>12hrly urine creatinin clearance<br /><br><br /><br>Clinical parameters:<br /><br>CAM-ICU delirium scale 8-hrly<br /><br>RASS sedation scale 8-hrly<br /><br>Need for fixation<br /><br>CVVH or dialysis<br /><br><br /><br>Medication:<br /><br>Total amounts and average daily doses of:<br /><br>Noradrenalin, dobutamine, midazolam, morfine, propofol, haloperidol, other<br /><br>antipsychotics.<br /><br><br /><br>Safety parameters:<br /><br>Adverse events<br /><br>Serious adverse events</p><br>