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Hemadsorption to Enhance Drug Elimination in Intoxications

NCT06922786 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-05-15

No results posted yet for this 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.

Conditions

  • Intoxication by Drug

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 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)

Sponsors & Collaborators

  • Universitair Ziekenhuis Brussel

    lead OTHER

Principal Investigators

  • Michaël Mekeirele, Medical Doctor · Universitair Ziekenhuis Brussel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2028-12-31
Completion
2029-01-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06922786 on ClinicalTrials.gov