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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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)
Universitair Ziekenhuis Brussel
Brussels, Brussels Capital, Belgium
RECRUITINGDifference 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.
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Adsorbability of the individual neurodepressing drugs
Comparing the pre- and post filter titer of the neurodepressing drug the adsorbability can be observed.
Time frame: 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
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Catheter related complications
Catheter related complications (eg bleeding, infection) will be noted
Time frame: From enrollment to the removal of the dialysis catheter +/- 3 days
Seizures during hemadsorption therapy
Seizures during hemadsorption therapy will be noted
Time frame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Bleeding during hemadsorption therapy
Bleeding during hemadsorption therapy will be noted
Time frame: 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
Time frame: From enrollment to discharge from ICU (+/- 1 week)
Duration mechanical ventilation
Time to extubation and stop of flumazenil will be noted
Time frame: From enrollment to extubation (+/- 3 days)
Duration ICU stay
Time to discharge will be noted
Time frame: From enrollment to discharge from ICU (+/- 1 week)
Need and duration vasopressors
Time untill discontinuation of vasopressors will be noted
Time frame: From enrollment to stop of vasopressors (+/- 3 days)
Marie-Claire vanmalderen, Study coordinator
CONTACT
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