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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023455-28-FI

Enrollment

Registered

2010-11-03

Start date

2010-12-15

Completion date

Unknown

Last updated

2014-11-03

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

Conditions

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

Interventions

Trade Name: Precedex Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: dexmedetomidine hydrochloride CAS Number: 145108-58-3 Current Sponsor code: 11102010 Other descript

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

Exclusion criteria: 1. Severe bradycardia (HR101 umol/l) 4. Pregnancy or lactation 5. Age <18

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Finland

Outcome results

None listed

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