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Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

Primary Purpose

Acute Kidney Injury

Status

Unknown status

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Dexmedetomidine

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring dexmedetomidine, pharmacokinetics, critical illness, continuous renal replacement therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18
Clinical need for sedation
Acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures)

Exclusion Criteria:

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

Sites / Locations

Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dexmedetomidine

Arm Description

Outcomes

Primary Outcome Measures

Dexmedetomidine clearance by continuous venovenous hemodialysis

Secondary Outcome Measures

Full Information

NCT ID

NCT01314209

First Posted

March 8, 2011

Last Updated

October 23, 2012

Sponsor

Helsinki University Central Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01314209

Brief Title

Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

Official Title

Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Unknown status

Study Start Date

March 2011 (undefined)

Primary Completion Date

March 2014 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Helsinki University Central Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous renal replacement therapy on critically ill patients.

Detailed Description

Dexmedetomidine is a selective alpha-2-adrenergic agonist with sedative properties indicated for sedation of patients in the intensive care setting. ICU patients with acute kidney injury requiring renal replacement therapies frequently have changes in volume status causing alterations in drug pharmacokinetics. Although dexmedetomidine pharmacokinetics have been studied earlier on ICU patients, there is no information on its pharmacokinetics in critically ill patients needing continuous renal replacement therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Kidney Injury

Keywords

dexmedetomidine, pharmacokinetics, critical illness, continuous renal replacement therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

dexmedetomidine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Dexmedetomidine

Intervention Description

Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion

Primary Outcome Measure Information:

Title

Dexmedetomidine clearance by continuous venovenous hemodialysis

Time Frame

10 hours from the start of the dexmedetomidine infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 Clinical need for sedation Acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures) Exclusion Criteria: Severe bradycardia (HR < 50/min) AV conduction block II-III (unless pacemaker installed) Severe hepatic impairment (bilirubin > 101 umol/l) Pregnancy or lactation Age < 18

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kirsi-Maija Kaukonen, MD, PhD

Phone

+358 50 4271059

maija.kaukonen@hus.fi

First Name & Middle Initial & Last Name or Official Title & Degree

Suvi Vaara, MD

Phone

+358 50 3312433

suvi.vaara@hus.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kirsi-Maija Kaukonen, MD, PhD

Organizational Affiliation

Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH

Official's Role

Principal Investigator

Facility Information:

Facility Name

Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kirsi-Maija Kaukonen, MD, PhD

Phone

+358 504271059

maija.kaukonen@hus.fi

First Name & Middle Initial & Last Name & Degree

Suvi Vaara, MD

Phone

+358 503312433

suvi.vaara@hus.fi

12. IPD Sharing Statement

Learn more about this trial

Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

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