NCT01314209

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 14, 2011

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Last Updated

October 24, 2012

Status Verified

March 1, 2011

Enrollment Period

3 years

First QC Date

March 8, 2011

Last Update Submit

October 23, 2012

Conditions

Acute Kidney Injury

Keywords

dexmedetomidinepharmacokineticscritical illnesscontinuous renal replacement therapy

Outcome Measures

Primary Outcomes (1)

  • Dexmedetomidine clearance by continuous venovenous hemodialysis

    10 hours from the start of the dexmedetomidine infusion

Study Arms (1)

dexmedetomidine

EXPERIMENTAL
Drug: Dexmedetomidine

Interventions

DexmedetomidineDRUG

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

dexmedetomidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Helsinki, 00290, Finland

RECRUITING

MeSH Terms

Conditions

Acute Kidney InjuryCritical Illness

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Kirsi-Maija Kaukonen, MD, PhD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirsi-Maija Kaukonen, MD, PhD

CONTACT

+358 50 4271059maija.kaukonen@hus.fi

Suvi Vaara, MD

CONTACT

+358 50 3312433suvi.vaara@hus.fi

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2011

First Posted

March 14, 2011

Study Start

March 1, 2011

Primary Completion

March 1, 2014

Last Updated

October 24, 2012

Record last verified: 2011-03

Locations

FI(1)