MedDataX Logo

Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)

NCT ID: NCT01314209

Last Updated: 2012-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Kidney Injury

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

dexmedetomidine pharmacokinetics critical illness continuous renal replacement therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dexmedetomidine

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dexmedetomidine

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Helsinki University Central Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kirsi-Maija Kaukonen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Helsinki, , Finland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Finland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Kirsi-Maija Kaukonen, MD, PhD

Role: CONTACT

Phone: +358 50 4271059

Email: [email protected]

Suvi Vaara, MD

Role: CONTACT

Phone: +358 50 3312433

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kirsi-Maija Kaukonen, MD, PhD

Role: primary

Suvi Vaara, MD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11102010

Identifier Type: -

Identifier Source: org_study_id