중독의 약물 제거를 향상시키기위한 혈액 흡착 (MATRIX)
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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
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.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 해당 없음
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Marie-Claire vanmalderen, Study coordinator
- 전화번호: 0032 24 76 31 10
- 이메일: Marieclaire.vanmalderen@uzbrussel.be
연구 연락처 백업
- 이름: Merel Stevens, Study coordinator
- 전화번호: 0032 24 76 30 96
- 이메일: Merel.stevens@uzbrussel.be
연구 장소
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Brussels Capital
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Brussels, Brussels Capital, 벨기에, 1090
- 모병
- Universitair Ziekenhuis Brussel
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연락하다:
- Marie-Claire Van Malderen, Study nurse
- 전화번호: 00324763110
- 이메일: marie-claire.vanmalderen@uzbrussel.be
-
연락하다:
- Merel Stevens, Study Nurse
- 전화번호: 00324763096
- 이메일: merel.stevens@uzbrussel.be
-
수석 연구원:
- Michaël Mekeirele, Medical Doctor
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: 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. |
Plasma titers neurodepressing drug:
Hemadsorption via dialysis catheter in patients still fulfilling inclusion criteria 8 hours after admission. Subsequent plasma titers pre- and post-hemadosorption filter:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Difference in time to upper limit of normal of the dosed drug with versus without hemadsorption
기간: 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. |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Adsorbability of the individual neurodepressing drugs
기간: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
Comparing the pre- and post filter titer of the neurodepressing drug the adsorbability can be observed. |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
|
Time to saturation of hemadsorption filter
기간: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
Comparing the pre- and post filter titer of the neurodepressing drug the time to saturation can be observed |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
|
Catheter related complications
기간: From enrollment to the removal of the dialysis catheter +/- 3 days
|
Catheter related complications (eg bleeding, infection) will be noted |
From enrollment to the removal of the dialysis catheter +/- 3 days
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Seizures during hemadsorption therapy
기간: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
Seizures during hemadsorption therapy will be noted |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
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Bleeding during hemadsorption therapy
기간: From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
Bleeding during hemadsorption therapy will be noted |
From enrollment to the end of treatment (cesation hemadsorption) +/- 3 days
|
|
Cost effectiveness of applying a Cytosorb® hemadsorption filter
기간: From enrollment to discharge from ICU (+/- 1 week)
|
Duration of ICU stay, duration of ventilation, cost of a hemadsorption filter and disposables amongst others will be used for an evaluation of cost effectiveness |
From enrollment to discharge from ICU (+/- 1 week)
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Duration mechanical ventilation
기간: From enrollment to extubation (+/- 3 days)
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Time to extubation and stop of flumazenil will be noted |
From enrollment to extubation (+/- 3 days)
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Duration ICU stay
기간: From enrollment to discharge from ICU (+/- 1 week)
|
Time to discharge will be noted |
From enrollment to discharge from ICU (+/- 1 week)
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Need and duration vasopressors
기간: From enrollment to stop of vasopressors (+/- 3 days)
|
Time untill discontinuation of vasopressors will be noted |
From enrollment to stop of vasopressors (+/- 3 days)
|
공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Michaël Mekeirele, Medical Doctor, Universitair Ziekenhuis Brussel
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- CIV-24-12-050174
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Single center study
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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