- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02826057
The Complement Lectin Pathway After Cardiac Arrest
The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.
The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.
The specific aim is to evaluate:
- the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
- the relation between concentration of plasma lectin pathway proteins and mortality
- if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins
This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"
The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Aarhus, 덴마크, 8000
- Department of Biomedicine, Aarhus University
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Aarhus, 덴마크, 8200
- Department of Anesthesiology and Intensive Care, Aarhus University Hospital
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Aarhus, 덴마크, 8200
- Department of Clinical Biochemistry, Aarhus University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Out-of-Hospital Cardiac Arrest of presumed cardiac cause
- Return of spontaneous circulation (ROSC)
- Glasgow Coma Score < 8
- Age > 18 years and < 80 years
Exclusion Criteria:
- > 60 minutes from the circulatory collapse to ROSC
- Time interval > 4 hours from cardiac arrest to initiation of targeted temperature management
- Terminal illness
- Coagulation disorder
- Unwitnessed asystolia
- Cerebral performance category 3-4 before the cardiac arrest
- Severe persistent cardiogenic shock
- Pregnancy
- Persistent cardiogenic shock (systolic bloodpressure < 80 despite inotropic treatment)
- New apoplexy or cerebral hemorrhage
- Lack of consent from the relatives
- Lack of consent from the general practitioner
- Lack of consent from the patient
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 24 hour of targeted temperature management
Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)
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실험적: 48 hour of targeted temperature management
Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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MASP-2 concentration in plasma
기간: 48 hours
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48 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
MASP-2 concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
|
|
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MASP-2 concentration in plasma
기간: 24 hours, 48 hours, 72 hours
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MASP-2 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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MASP-2 concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
|
|
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MASP-1 concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
|
|
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MASP-1 concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
|
|
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MASP-1 concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
MASP-1 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
|
|
MASP-3 concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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MASP-3 concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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MASP-3 concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
MASP-3 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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Mannan-Binding-Lectin concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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Mannan-Binding-Lectin concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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Mannan-Binding-Lectin concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
|
24 hours, 48 hours, 72 hours
|
|
MAp44 concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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|
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Map44 concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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|
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MAp44 concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
MAp44 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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|
MAp19 concentration in plasma
기간: 24 hours, 48 hours and 72 hours
|
24 hours, 48 hours and 72 hours
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MAp19 concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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MAp19 concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
MAp19 concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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|
H-ficolin concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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H-ficolin concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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H-ficolin concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
H-ficolin concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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M-ficolin concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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M-ficolin concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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M-ficolin concentration in plasma
기간: 24 hours, 48 hours, 72 hours
|
M-ficolin concentration in plasma compared with 30-day mortality
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24 hours, 48 hours, 72 hours
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CL-L1 concentration in plasma
기간: 24 hours, 48 hours and 72 hours
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24 hours, 48 hours and 72 hours
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CL-L1 concentration in plasma
기간: 24 hours to 72 hours
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24 hours to 72 hours
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CL-L1 concentration in plasma
기간: 24 hours, 48 hours, 72 hours
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CL-L1 concentration in plasma compared with 30-day mortality
|
24 hours, 48 hours, 72 hours
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .