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Hemadsorption to Enhance Drug Elimination in Intoxications

Sponsor: Universitair Ziekenhuis Brussel • ClinicalTrials.gov ID: NCT06922786

Registry updated: 2026-09-23

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Description

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.

Interventions

Hemadsorption filter (Device)
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)

Eligibility criteria

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

Conditions

Intoxication by Drug

Locations

Universitair Ziekenhuis Brussel — Brussels, Brussels Capital, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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