Hemadsorption to Enhance Drug Elimination in Intoxications

NCT06922786 | Recruiting DMC

• 1 other identifier: CIV-24-12-050174
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Benzodiazepine; Tricyclic antidepressant; Intoxication; Hemadsorption

Outcome Measures

Primary Outcomes (1)

• Difference 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.

  From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Secondary Outcomes (9)

• Adsorbability of the individual neurodepressing drugs

  From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

• Time to saturation of hemadsorption filter

  From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

• Catheter related complications

  From enrollment to the removal of the dialysis catheter +/- 3 days

• Seizures during hemadsorption therapy

  From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

• Bleeding during hemadsorption therapy

  From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days

Study Arms (1)

Hemadsorption

EXPERIMENTAL

Hemadsorption via a dialysis catheter will be performed in patients who are unconscious due to an intoxication with quantifiable benzodiazepines or tricyclic antidepressants 8 hours after admission. Before and after application fo this hemadsorption filter plasma titers of this drug will be obtained. After application of the hemadsorption filter pre- and post-filter titers will be obtained.

Device: Hemadsorption 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)

Hemadsorption

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, 1090, Belgium

RECRUITING

Study Officials

• Michaël Mekeirele, Medical Doctor

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Claire vanmalderen, Study coordinator

CONTACT

0032 24 76 31 10; Marieclaire.vanmalderen@uzbrussel.be

Merel Stevens, Study coordinator

CONTACT

0032 24 76 30 96; Merel.stevens@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: April 10, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)