Intoxication by DrugMATRIXNCT06922786
Hemadsorption to Enhance Drug Elimination in Intoxications
A study testing Hemadsorption filter in people with Intoxication by Drug, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intoxication by Drug
- What is being tested?
- Hemadsorption filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- 1 May 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie-Claire vanmalderen, Study coordinator contact
Belgium1 site, 1 recruiting
- Recruiting
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, 1090
Marie-Claire Van Malderen, Study nurse, 00324763110, marie-claire.vanmalderen@uzbrussel.be
Merel Stevens, Study Nurse, 00324763096, merel.stevens@uzbrussel.be
About this study
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.
Read the detailed description
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.
- Conditions
- Intoxication by Drug
- Being tested
- Hemadsorption filter
- Keywords
- Benzodiazepine, Tricyclic antidepressant, Intoxication, Hemadsorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemadsorption filterDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| Hemadsorption | Experimental | Hemadsorption via a dialysis catheter will be performed in patients who are unconscious due to an intoxication with quantifiable benzodiazepines or tricyclic antidepressants 8 hours after admission. Before and after application fo this hemadsorption filter plasma titers of this drug will be obtained. After application of the hemadsorption filter pre- and post-filter titers will be obtained. Receives: Device: Hemadsorption filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Secondary outcomes (9)
Adsorbability of the individual neurodepressing drugs
Comparing the pre- and post filter titer of the neurodepressing drug the adsorbability can be observed.
Measured: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Time to saturation of hemadsorption filter
Comparing the pre- and post filter titer of the neurodepressing drug the time to saturation can be observed
Measured: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Catheter related complications
Catheter related complications (eg bleeding, infection) will be noted
Measured: From enrollment to the removal of the dialysis catheter +/- 3 days
Seizures during hemadsorption therapy
Seizures during hemadsorption therapy will be noted
Measured: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Bleeding during hemadsorption therapy
Bleeding during hemadsorption therapy will be noted
Measured: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Cost effectiveness of applying a Cytosorb® hemadsorption filter
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
Measured: From enrollment to discharge from ICU (+/- 1 week)
Duration mechanical ventilation
Time to extubation and stop of flumazenil will be noted
Measured: From enrollment to extubation (+/- 3 days)
Duration ICU stay
Time to discharge will be noted
Measured: From enrollment to discharge from ICU (+/- 1 week)
Need and duration vasopressors
Time untill discontinuation of vasopressors will be noted
Measured: From enrollment to stop of vasopressors (+/- 3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 May 2025
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intoxication by DrugStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michaël Mekeirele, Medical Doctor, Principal investigator, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922786
- Sponsor's protocol ID
- CIV-24-12-050174
- Acronym
- MATRIX
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Single center study
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemadsorption to Enhance Drug Elimination in Intoxications
- ClinicalTrials.gov ID
- NCT06922786
- Acronym / sponsor ID
- MATRIX / CIV-24-12-050174
- Conditions
- Intoxication by Drug
- Keywords
- Benzodiazepine, Tricyclic antidepressant, Intoxication, Hemadsorption
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 10 Apr 2025 (actual)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemadsorption | Experimental | Device: Hemadsorption filterHemadsorption via a dialysis catheter will be performed in patients who are unconscious due to an intoxication with quantifiable benzodiazepines or tricyclic antidepressants 8 hours after admission. Before and after application fo this hemadsorption filter plasma titers of this drug will be obtained. After application of the hemadsorption filter pre- and post-filter titers will be obtained. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Hemadsorption filterPlasma 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) | Device | Hemadsorption |
Primary outcome
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.
9 secondary outcomes
Adsorbability of the individual neurodepressing drugs
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Time to saturation of hemadsorption filter
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Catheter related complications
Time frame: From enrollment to the removal of the dialysis catheter +/- 3 days
Seizures during hemadsorption therapy
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Bleeding during hemadsorption therapy
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Cost effectiveness of applying a Cytosorb® hemadsorption filter
Time frame: From enrollment to discharge from ICU (+/- 1 week)
Duration mechanical ventilation
Time frame: From enrollment to extubation (+/- 3 days)
Duration ICU stay
Time frame: From enrollment to discharge from ICU (+/- 1 week)
Need and duration vasopressors
Time frame: From enrollment to stop of vasopressors (+/- 3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No. Single center study
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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.
Marie-Claire vanmalderen, Study coordinator contact
Michaël Mekeirele, Medical Doctor principal investigator
Universitair Ziekenhuis Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemadsorption filter in people with Intoxication by Drug, run by Universitair Ziekenhuis Brussel at 1 site 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 5 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Sep 2026. 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 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Claire vanmalderen, Study coordinator (0032 24 76 31 10, Marieclaire.vanmalderen@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 23 Sep 2026.