Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C (PCA)
The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).
This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 4단계
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients with septic shock as determined by standard criteria (including infection and severe infection)
Exclusion Criteria:
- Pregnant women
- Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
- Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy >= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count < 30000 x 10^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Shock + Treatment
Patients treated with activated protein C
|
24 μg/kg/h during 96 hours - intravenous injection
다른 이름들:
After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated.
Reactive hyperthermia is measured.
It is considered as an index for endothelial function.
Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema. Arterial tension through an invasive approach is measured during the test.
Analysis of inflammation and cellular adhesion markers and free radicals
|
|
다른: Shock
Patients not treated with activated protein C
|
After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated.
Reactive hyperthermia is measured.
It is considered as an index for endothelial function.
Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema. Arterial tension through an invasive approach is measured during the test.
Analysis of inflammation and cellular adhesion markers and free radicals
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Vascular reactivity measured with dose-response to phenylephrine
기간: baseline
|
baseline
|
|
Vascular reactivity measured with dose-response to phenylephrine
기간: 4 hours
|
4 hours
|
|
Vascular reactivity measured with dose-response to phenylephrine
기간: 24 hours
|
24 hours
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Bruno LEVY, Réanimation Médicale - Hôpital de Brabois - CHRU Nancy
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 2007-002319-16
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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