Clinical trial NCT06922786: Hemadsorption to Enhance Drug Elimination in Intoxications
Official title: Hemadsorption to Enhance Drug Elimination in Intoxications
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intoxication by Drug
Keywords: Benzodiazepine
Tricyclic antidepressant
Intoxication
Hemadsorption
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption
timeFrame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
Secondary outcomes:
measure: Adsorbability of the individual neurodepressing drugs
timeFrame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
measure: Time to saturation of hemadsorption filter
timeFrame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
measure: Catheter related complications
timeFrame: From enrollment to the removal of the dialysis catheter +/- 3 days
measure: Seizures during hemadsorption therapy
timeFrame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
measure: Bleeding during hemadsorption therapy
timeFrame: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
measure: Cost effectiveness of applying a Cytosorb® hemadsorption filter
timeFrame: From enrollment to discharge from ICU (+/- 1 week)
measure: Duration mechanical ventilation
timeFrame: From enrollment to extubation (+/- 3 days)
measure: Duration ICU stay
timeFrame: From enrollment to discharge from ICU (+/- 1 week)
measure: Need and duration vasopressors
timeFrame: From enrollment to stop of vasopressors (+/- 3 days)
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussels hoofdstedelijk gewest
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Michaël Mekeirele, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: