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NCT Number: NCT06922786

Hemadsorption to Enhance Drug Elimination in Intoxications

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

Location status: Recruiting

Location contact

Marie-Claire Van Malderen, Study nurse

CONTACT

[email protected]

00324763110

Merel Stevens, Study Nurse

CONTACT

[email protected]

00324763096

Michaël Mekeirele, Medical Doctor

PRINCIPAL_INVESTIGATOR

About this study

In this prospective interventional study with medical device, the investigotors would include 18 patients admitted to ICU after an intoxication with a quantifiable neurodepressing drugs (type benzodiazepines or tricyclic antidepressants) and with impaired consciousness defined as need for intubation or need for Flumazenil to prevent intubation. Naloxone is administered per standard of care to identify if opioid intoxications is the main reason of neurodepression. Patients requiring mechanical ventilation for other reasons than impaired consciousness due to this intoxication or indication for prolonged use of sedatives are excluded.

Patients with at least one risk factor for delayed drug elimination (Chronic kidney disease G3b or CHILD-Pugh B or C) and persisting impaired consciousness after eight hours (including patients with persisting need for flumazenil) and having 5 plasma titers of the neurodepressing drug with intervals of 2 hours will be initiated on a hemadsorption filter after contact between the treating team and either dr. Michaël Mekeirele or dr. Tim Balthazar to verify inclusion criteria. Patients fulfilling inclusion criteria but lacking the 5 plasma titers will get additional plasma titers with intervals of 2 hours until 5 plasma titers are obtained. If these patients still fulfill inclusion criteria at that time then a hemadosorption filter will be initiated.

After starting hemadsorption a plasma titer pre- and post filter will be obtained after 15 minutes and every 4 hours after starting hemadsorption for the first 24 hours. After this timepoint additional plasma titers will be obtained every 24 hours until stopping hemadsorption or normalisation of the plasma titer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Having a risk factor for delayed drug elimination defined as either Cirrhosis CHILD B/C or chronic kidney insufficiency KDIGO 3b or worse

Exclusion criteria

  • 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
  • Known history of seizures
  • Contra-indication to heparin use
  • DNR restricting the use of mechanical ventilation or dialysis

Treatment and study plan

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)

Primary outcomes

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

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

    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.

Secondary outcomes

  1. Adsorbability of the individual neurodepressing drugs

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

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

  2. Time to saturation of hemadsorption filter

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

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

  3. Catheter related complications

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

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

  4. Seizures during hemadsorption therapy

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

    Seizures during hemadsorption therapy will be noted

  5. Bleeding during hemadsorption therapy

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

    Bleeding during hemadsorption therapy will be noted

  6. Cost effectiveness of applying a Cytosorb® hemadsorption filter

    Time frame: From enrollment to discharge from ICU (+/- 1 week)

    Duration of ICU stay, duration of ventilation, cost of a hemadsorption filter and disposables amongst others will be used for an evaluation of cost effectiveness

  7. Duration mechanical ventilation

    Time frame: From enrollment to extubation (+/- 3 days)

    Time to extubation and stop of flumazenil will be noted

  8. Duration ICU stay

    Time frame: From enrollment to discharge from ICU (+/- 1 week)

    Time to discharge will be noted

  9. Need and duration vasopressors

    Time frame: From enrollment to stop of vasopressors (+/- 3 days)

    Time untill discontinuation of vasopressors will be noted

Study contacts

Contact information is provided by the study sponsor or research team.

Marie-Claire vanmalderen, Study coordinator

CONTACT

[email protected]

0032 24 76 31 10

Merel Stevens, Study coordinator

CONTACT

[email protected]

0032 24 76 30 96

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Acronym: MATRIX

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Apr 10, 2025
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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