Acute Kidney InjuryPhase 2/3NCT01314209
Dexmedetomidine Pharmacokinetics During Continuous Renal Replacement Therapy (CRRT)
A Phase 2/3 study testing Dexmedetomidine in people with Acute Kidney Injury, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous renal replacement therapy on critically ill patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2011to Mar 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Clinical need for sedation
- Acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Meilahti Hospital, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, Helsinki University Central Hospital
Helsinki, 00290
Kirsi-Maija Kaukonen, MD, PhD, +358 504271059, maija.kaukonen@hus.fi
Suvi Vaara, MD, +358 503312433, suvi.vaara@hus.fi
About this study
Official title: Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients
The purpose of this study is to determine dexmedetomidine pharmacokinetics during continuous renal replacement therapy on critically ill patients.
Read the 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.
- Conditions
- Acute Kidney Injury
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine, pharmacokinetics, critical illness, continuous renal replacement therapy
- Medical subject headings
- Acute Kidney Injury, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine | Experimental | Not described Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dexmedetomidine clearance by continuous venovenous hemodialysis
Measured: 10 hours from the start of the dexmedetomidine infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Kirsi-Maija Kaukonen, MD, PhD, Principal investigator, Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01314209
- Sponsor's protocol ID
- 11102010
- Status last verified
- Mar 2011
- First submitted
- 8 Mar 2011
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine Pharmacokinetics During Continuous Venovenous Hemodialysis in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01314209
- Acronym / sponsor ID
- 11102010
- Conditions
- Acute Kidney Injury
- Keywords
- dexmedetomidine, pharmacokinetics, critical illness, continuous renal replacement therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Mar 2014 (estimated)
- First posted
- 14 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine | Experimental | Drug: Dexmedetomidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Clinical need for sedation
- Acute kidney injury requiring renal replacement therapy (according to ICUs standard operating procedures)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineDexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion | Drug | dexmedetomidine |
Primary outcome
Dexmedetomidine clearance by continuous venovenous hemodialysis
Time frame: 10 hours from the start of the dexmedetomidine infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsi-Maija Kaukonen, MD, PhD principal investigator
Division of Anaesthesia and Intensive Care Medicine, Department of Surgery, HUCH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine in people with Acute Kidney Injury, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kirsi-Maija Kaukonen, MD, PhD (+358 50 4271059, maija.kaukonen@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dexmedetomidine clearance by continuous venovenous hemodialysis (time frame: 10 hours from the start of the dexmedetomidine infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.