Hemadsorption to Enhance Drug Elimination in Intoxications

NCT ID: NCT06922786

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2029-01-31

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.

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.

Conditions

Intoxication by Drug

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemadsorption

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.

Group Type: EXPERIMENTAL

Hemadsorption filter

Intervention Type: 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)

Interventions

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)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Michaël Mekeirele

Medical Doctor, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michaël Mekeirele, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Universitair Ziekenhuis Brussel

Brussels, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Marie-Claire vanmalderen, Study coordinator

Role: CONTACT

Marieclaire.vanmalderen@uzbrussel.be

0032 24 76 31 10

Merel Stevens, Study coordinator

Role: CONTACT

Merel.stevens@uzbrussel.be

0032 24 76 30 96

Facility Contacts

Marie-Claire Van Malderen, Study nurse

Role: primary

marie-claire.vanmalderen@uzbrussel.be

00324763110

Merel Stevens, Study Nurse

Role: backup

merel.stevens@uzbrussel.be

00324763096

Other Identifiers

CIV-24-12-050174

Identifier Type: -

Identifier Source: org_study_id