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Respiratory FailurePhase 3NCT01076816

Dexmedetomidine Pharmacokinetics-pharmacodynamics in Mechanically Ventilated Children With Single-organ Respiratory Failure

A Phase 3 study testing dexmedetomidine, Vital signs and blood sampling in people with Respiratory Failure, run by University Hospital, Ghent at 2 sites in Belgium.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Read more about this study

Who is it for?
Ages 1 month to 15 years
Conditions the study is for
Respiratory Failure
What is being tested?
dexmedetomidine, Vital signs and blood sampling
How many people
1 participants
Where
2 sitesBelgium
Study dates
Dec 2009to May 2011
Phase
Phase 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 1 month to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • patients (m/f) admitted to the paediatric intensive care unit
  • expected to require at least 24h of mechanical ventilation
  • patient age : 1 month-15 years
  • patients with single-organ respiratory failure

Who cannot join

  • patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
  • no arterial catheter in place at inclusion
  • patients who have received another investigational drug within 30 days
  • patients on continuous infusion with neuromuscular blockers
  • patients with a life expectancy <72h
  • patients with a known allergy to lorazepam, midazolam and/or morphine
Show all 12Show fewer
  • heart block
  • pre-existing bradycardia
  • hemodynamically unstable patients (Wernovsky index > 16 points) after full fluid replacement with crystalloid
  • patients with significant renal insufficiency (creatinine plasma level 1 month-5 year : > 1 mg/dl ; 5-10 years : >1.2 mg/dl; > 10 years : > 1.5 mg/dl)
  • patients with significant hepatic insufficiency (aspartate aminase >950 UI/L and prothrombin time < 60 or INR >1.4)
  • previous treatment with α2-adrenoreceptor agonist clonidine within 14 days

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • University Hospital Ghent

    Ghent

Other trials in Belgium

About this study

Currently, dexmedetomidine is approved by the United States Food and Drug Administration (FDA) for short-term analgosedation (<24h) in mechanically-ventilated critical care adult patients and sedation of non-intubated adult patients prior to and/or during surgical and other procedures. Trials are underway to investigate its pharmacokinetics, clinical efficacy and safety in long-term use. Clinical experience with dexmedetomidine in the paediatric population is limited. Moreover, during childhood many developmental changes take place with consequences on drug exposure and drug response. Finally, critical illness itself can affect drug pharmacokinetics and -dynamics. Therefore, we cannot simply extrapolate adult data for use in children but we are in need of data on pharmacokinetics and pharmacodynamics in every paediatric subpopulation.

Being tested
dexmedetomidine, Vital signs, blood sampling
Keywords
Patients with single-organ failure in need of mechanical ventilation
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dexmedetomidineDrug

    dexmedetomidine will be given max 48h. In case analgosedation is still needed after stop of the dexmedetomidine infusion, the treatment is switched to conventional analgosedation regimens.

    Additional drugs are given to every inadequately sedated patient (assessed by regular Comfort scoring). In case of oversedation or adverse drug events (hypotension, bradycardia), a downtitration (or stop) of the dexmedetomidine infusion is needed.

  • Vital signsProcedure or surgery

    systolic and diastolic blood pressure, heart rate, respiratory rate,oxygen saturation, temperature are assessed baseline and at least per hour reassessed after starting the dexmedetomidine.

  • blood samplingProcedure or surgery

    Blood sampling for pharmacokinetic modelling is limited to a maximum of 1,8 ml/kg (in line with the EMEA guidelines on maximum blood sampling in children). Pharmacokinetic parameters and influence of covariates on these parameters will be assessed by a population pharmacokinetic approach.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure

    Measured: 48 hours

  2. covariates contributing to a variability in exposure and response to dexmedetomidine

    Measured: 48 hours

Secondary outcomes (3)

  1. preliminary knowledge on the level of sedation provided by dexmedetomidine

    Measured: 48 hours

  2. preliminary knowledge of safety issues

    systolic and diastolic blood pressure, heart rate, respiratory rate, oxygen saturation, temperature are assessed baseline and at least per hour reassessed after starting the dexmedetomidine infusion

    Measured: 48 hours

  3. knowledge of the contribution of the CYP2A6 and UDP-glucuronosyltransferase genotype (covariate) to the variability in exposure and response to dexmedetomidine

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2010 (estimated)
  2. Study startDec 2009
  3. Primary completionFeb 2011
  4. Study completionMay 2011

Why it stopped: Poor inclusion rate.

Resources

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 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01076816
Sponsor's protocol ID
2009/518
Status last verified
Oct 2011
First submitted
25 Feb 2010
Last updated
4 Oct 2011
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing dexmedetomidine, Vital signs and blood sampling in people with Respiratory Failure, run by University Hospital, Ghent at 2 sites in Belgium.

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 4 inclusion and 12 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: stopped early, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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 phase mean?

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?

The study was stopped early (reason given: Poor inclusion rate.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pharmacokinetic parameters of dexmedetomidine infusion in mechanically ventilated children with single-organ respiratory failure (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01076816.

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 4 Oct 2011.

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