Hemadsorption to Enhance Drug Elimination in Intoxications

NCT06922786 · tracked via the Priya Life Science Belgium tracker

Sponsor

Universitair Ziekenhuis Brussel

Phase

Not applicable

Started

2025-05-01

Last updated

2026-09-23

Condition(s) studied

Intoxication by Drug

Investigational drug(s) / intervention(s)

Hemadsorption filter

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 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)

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption — From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
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.

Trial sites (1)

Facility	City	Region	Status
Universitair Ziekenhuis Brussel	Brussels	Brussels Capital	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06922786 on ClinicalTrials.gov ↗ ← All trials in Belgium