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Emadsorbimento per migliorare l'eliminazione dei farmaci nelle intossicazioni (MATRIX)

18 settembre 2026 aggiornato da: Universitair Ziekenhuis Brussel

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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

18

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Belgio
    • Brussels Capital
      • Brussels, Brussels Capital, Belgio, 1090
        • Reclutamento
        • Universitair Ziekenhuis Brussel
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Michaël Mekeirele, Medical Doctor

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. older than18 years
  2. Admission to ICU
  3. GCS < 8 or requiring Flumazenil 8 hours after hospital admission
  4. Having an intoxication with a benzodiazepine or tricyclic antidepressant that we can measure/quantify
  5. 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:

  1. Pregnant patient
  2. Patients in chronic dialysis before admission
  3. Need for mechanical ventilation for other reasons than intoxications (e.g. pneumonia, neurotrauma)
  4. Concomitant pathology requiring continued intravenous sedation
  5. Known history of seizures
  6. Contra-indication to heparin use
  7. DNR restricting the use of mechanical ventilation or dialysis

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Hemadsorption

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.
Dispositivo: Hemadsorption filter

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)

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption
Lasso di tempo: 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.
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adsorbability of the individual neurodepressing drugs
Lasso di tempo: 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.
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Time to saturation of hemadsorption filter
Lasso di tempo: 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
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Catheter related complications
Lasso di tempo: From enrollment to the removal of the dialysis catheter +/- 3 days

Catheter related complications (eg bleeding, infection) will be noted
From enrollment to the removal of the dialysis catheter +/- 3 days
Seizures during hemadsorption therapy
Lasso di tempo: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Seizures during hemadsorption therapy will be noted
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Bleeding during hemadsorption therapy
Lasso di tempo: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Bleeding during hemadsorption therapy will be noted
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Cost effectiveness of applying a Cytosorb® hemadsorption filter
Lasso di tempo: 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
From enrollment to discharge from ICU (+/- 1 week)
Duration mechanical ventilation
Lasso di tempo: From enrollment to extubation (+/- 3 days)

Time to extubation and stop of flumazenil will be noted
From enrollment to extubation (+/- 3 days)
Duration ICU stay
Lasso di tempo: From enrollment to discharge from ICU (+/- 1 week)

Time to discharge will be noted
From enrollment to discharge from ICU (+/- 1 week)
Need and duration vasopressors
Lasso di tempo: From enrollment to stop of vasopressors (+/- 3 days)

Time untill discontinuation of vasopressors will be noted
From enrollment to stop of vasopressors (+/- 3 days)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Universitair Ziekenhuis Brussel

Investigatori

  • Investigatore principale: Michaël Mekeirele, Medical Doctor, Universitair Ziekenhuis Brussel

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 maggio 2025

Completamento primario (Stimato)

1 dicembre 2028

Completamento dello studio (Stimato)

1 gennaio 2029

Date di iscrizione allo studio

Primo inviato

2 aprile 2025

Primo inviato che soddisfa i criteri di controllo qualità

3 aprile 2025

Primo Inserito (Effettivo)

10 aprile 2025

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

23 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • CIV-24-12-050174

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Single center study

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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