Hemadsorpce pro zvýšení eliminace léčiva v intoxikacích (MATRIX)
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Marie-Claire vanmalderen, Study coordinator
- Telefonní číslo: 0032 24 76 31 10
- E-mail: Marieclaire.vanmalderen@uzbrussel.be
Studijní záloha kontaktů
- Jméno: Merel Stevens, Study coordinator
- Telefonní číslo: 0032 24 76 30 96
- E-mail: Merel.stevens@uzbrussel.be
Studijní místa
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Brussels Capital
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Brussels, Brussels Capital, Belgie, 1090
- Nábor
- Universitair Ziekenhuis Brussel
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Kontakt:
- Marie-Claire Van Malderen, Study nurse
- Telefonní číslo: 00324763110
- E-mail: marie-claire.vanmalderen@uzbrussel.be
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Kontakt:
- Merel Stevens, Study Nurse
- Telefonní číslo: 00324763096
- E-mail: merel.stevens@uzbrussel.be
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Vrchní vyšetřovatel:
- Michaël Mekeirele, Medical Doctor
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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. |
Plasma titers neurodepressing drug:
Hemadsorption via dialysis catheter in patients still fulfilling inclusion criteria 8 hours after admission. Subsequent plasma titers pre- and post-hemadosorption filter:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption
Časové okno: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Adsorbability of the individual neurodepressing drugs
Časové okno: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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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
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Time to saturation of hemadsorption filter
Časové okno: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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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
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Catheter related complications
Časové okno: From enrollment to the removal of the dialysis catheter +/- 3 days
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Catheter related complications (eg bleeding, infection) will be noted |
From enrollment to the removal of the dialysis catheter +/- 3 days
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Seizures during hemadsorption therapy
Časové okno: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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Seizures during hemadsorption therapy will be noted |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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Bleeding during hemadsorption therapy
Časové okno: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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Bleeding during hemadsorption therapy will be noted |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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Cost effectiveness of applying a Cytosorb® hemadsorption filter
Časové okno: From enrollment to discharge from ICU (+/- 1 week)
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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)
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Duration mechanical ventilation
Časové okno: From enrollment to extubation (+/- 3 days)
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Time to extubation and stop of flumazenil will be noted |
From enrollment to extubation (+/- 3 days)
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Duration ICU stay
Časové okno: From enrollment to discharge from ICU (+/- 1 week)
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Time to discharge will be noted |
From enrollment to discharge from ICU (+/- 1 week)
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Need and duration vasopressors
Časové okno: From enrollment to stop of vasopressors (+/- 3 days)
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Time untill discontinuation of vasopressors will be noted |
From enrollment to stop of vasopressors (+/- 3 days)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Michaël Mekeirele, Medical Doctor, Universitair Ziekenhuis Brussel
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CIV-24-12-050174
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Single center study
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