Hemadsorpcja w celu zwiększenia eliminacji leku w zatruciu (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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
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 studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Marie-Claire vanmalderen, Study coordinator
- Numer telefonu: 0032 24 76 31 10
- E-mail: Marieclaire.vanmalderen@uzbrussel.be
Kopia zapasowa kontaktu do badania
- Nazwa: Merel Stevens, Study coordinator
- Numer telefonu: 0032 24 76 30 96
- E-mail: Merel.stevens@uzbrussel.be
Lokalizacje studiów
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Brussels Capital
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Brussels, Brussels Capital, Belgia, 1090
- Rekrutacyjny
- Universitair Ziekenhuis Brussel
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Kontakt:
- Marie-Claire Van Malderen, Study nurse
- Numer telefonu: 00324763110
- E-mail: marie-claire.vanmalderen@uzbrussel.be
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Kontakt:
- Merel Stevens, Study Nurse
- Numer telefonu: 00324763096
- E-mail: merel.stevens@uzbrussel.be
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Główny śledczy:
- Michaël Mekeirele, Medical Doctor
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Eksperymentalny: 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 mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Adsorbability of the individual neurodepressing drugs
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Michaël Mekeirele, Medical Doctor, Universitair Ziekenhuis Brussel
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Inne numery identyfikacyjne badania
- CIV-24-12-050174
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Single center study
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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