Dexmedetomidine pharmacokinetics during continuous venovenous hemofiltration and hemodiafiltration in critically ill patients - Dexmedetomidine study

Conditions: Intensive care patients with acute kidney injury requiring continuous renal replacement therapy with a clinical indication for sedation
MedDRA version: 12.1Level: LLTClassification code 10069339Term: Acute kidney injury

Registration Number: EUCTR2010-023455-28-FI

Lead Sponsor: Maija Kaukonen

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

1. age = 18
2. clinical need for sedation
3. acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures, one or more of the following criteria)
-oliguria (diuresis < 200ml/12h) or anuria
-severe acidosis (pH < 7.1-7.2) or rapidly deteriorating acidosis
-hyperpotassemia
-urea > 30 mmol/l and/or creatinine >500 umol/l or uremic complications (encephalopatia, pericarditis)
-significant fluid retention (high IAP, pulmonary oedema, severe peripheral oedema)
-rhabdomyolysis
-especially the combination of oliguria and deteriorating acidosis and/or hyperpotassemia is an indication for early initiation of renal replacement therapy

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Severe bradycardia (HR<50/min)
2. AV conduction block II-III (unless pacemaker installed)
3. Severe hepatic impairment (bilirubin >101 umol/l)
4. Pregnancy or lactation
5. Age <18

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the pharmacokinetics of dexmedetomidine during continuous venovenous hemofiltration and hemodialfiltration in critically ill patients. The measured values will be Cltot, ClCVVH(DF), Vd, T½, the amount of dexmedetomidine in ultrafiltrate and urine.;Secondary Objective: none;Primary end point(s): This is a descriptive study aiming to determine dexmedetomidine clearance during continuous venovenous hemofiltration and hemodiafiltration.

Secondary Outcome Measures