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Hemadsorption to Enhance Drug Elimination in Intoxications

ConditionIntoxication by Drug
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitair Ziekenhuis Brussel

About this trial

In this trial the investigators assess the effectiveness of applying a hemadsorber (cytosorb®) in removing benzodiazepines or tricyclic antidepressants in intoxicated patients admitted to ICU with prolonged impaired consciousness. This is a one arm interventional investigation where a hemadsorption filter is applied in patients fulfilling inclusion criteria 8 hours after admission. Plasma titer of the neurodepressing drug will be collected sequentially both before and after start of hemadsorption to evaluate the speed of drug elimination before and after application of a hemadsorption filter. Pre- and post filter titers will be obtained to evaluate adsorbability and to evaluate time to saturation of the filter.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

older than18 years

Admission to ICU

GCS < 8 or requiring Flumazenil 8 hours after hospital admission

Having an intoxication with a benzodiazepine or tricyclic antidepressant that we can measure/quantify

Disqualifiers

Pregnant patient

Patients in chronic dialysis before admission

Need for mechanical ventilation for other reasons than intoxications (e.g. pneumonia, neurotrauma)

Concomitant pathology requiring continued intravenous sedation

Trial design

Design model

Single group

Treatments tested in this trial

  • Hemadsorption filter

    Device

    Plasma titers neurodepressing drug: * At admission to the hospital (standard of care) * 2 hours after admission (+/- 15 minutes) * 4 hours after admission (+/- 15 minutes) * 6 hours after admission (+/- 15 minutes) * 8 hours after admission (+/- 15 minutes) * Just before start hemadsorption Hemadsorption via dialysis catheter in patients still fulfilling inclusion criteria 8 hours after admission. Subsequent plasma titers pre- and post-hemadosorption filter: * 15 minutes after start of hemadsorption (+ 15 minutes) * 4 hours after start of hemadsorption (+/- 15 minutes) * 8 hours after start of hemadsorption (+/- 15 minutes) * 12 hours after start of hemadsorption (+/- 15 minutes) * 16 hours after start of hemadsorption (+/- 15 minutes) * 20 hours after start of hemadsorption (+/- 15 minutes) * 24 hours after start of hemadsorption (+/- 15 minutes) * Every other 24 hours until cessation of hemadsorption or normalization of the plasma titer (+/- 15 minutes)

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: HemadsorptionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption

Based on plasma titers before start of hemadsorption the half life of the drug can be calculated. A theoretical intersection with the upper boundary of normal of the intoxicated drug plasma titer can be calculated. This will be statistically compared to the real time of attaining this titer after start of hemadsorption.

Time frame
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Secondary outcomes

1

Adsorbability of the individual neurodepressing drugs

Comparing the pre- and post filter titer of the neurodepressing drug the adsorbability can be observed.

Time frame
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
2

Time to saturation of hemadsorption filter

Comparing the pre- and post filter titer of the neurodepressing drug the time to saturation can be observed

Time frame
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
3

Catheter related complications

Catheter related complications (eg bleeding, infection) will be noted

Time frame
From enrollment to the removal of the dialysis catheter +/- 3 days
4

Seizures during hemadsorption therapy

Seizures during hemadsorption therapy will be noted

Time frame
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universitair Ziekenhuis Brussel

Lead sponsor

Source ClinicalTrials.gov
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