Hemadsorption to Enhance Drug Elimination in Intoxications
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Hemadsorption filter.
- Who it may be relevant to
- Registry conditions: Intoxication by Drug. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device 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 hemad
Primary outcome measures
- 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]
Secondary outcome measures (9)
- 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)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Universitair Ziekenhuis Brussel — Brussels
Identifiers
NCT: NCT06922786 · CIV-24-12-050174