Microcirculation After MAP Increase in Septic Shock Patients With Previous Hypertension
연구 개요
상세 설명
Hypothesis: After a rise in mean arterial pressure, microcirculation improvement will occur only in the previously hypertensive patients.
Study design: Prospective clinical trial Setting: Intensive care units of the Anesthesiology Department at the Federal University of Sao Paulo and the intensive care unit of Kidney Hospital.
Studied population: Forty patients will be included, being 20 without known history of systemic arterial hypertension and 20 with this diagnosis for at least 2 years and already with clinical or subclinical organ damage.
Inclusion criteria: age over than 18 years old, norepinephrine drug use for at least 12 hours and for less than 72 hours, sedation level equal or deeper than Ramsay 4, blood pressure stable for the last 30 minutes prior to inclusion, central venous catheter in place and signed informed consent.
Exclusion criteria: pregnancy, cirrhosis, systemic sclerosis, and need to maintain mean arterial pressure above 65mmHg for others conditions.
Intervention: noradrenaline dose will be risen to obtain a mean arterial pressure of 85-90 mmHg.
Assessments and outcome: Systemic hemodynamic (central venous oxygen saturation, cardiac output, heart rate, central venous pressure) and sublingual microcirculation variables (microcirculatory flow index, total vascular density, proportion of perfused vessels, perfused vascular density) will be measured before and after the rise in mean arterial pressure. Sidestream darkfield will be used to assess microcirculation. The variation between those variables before and after the intervention will be compared.
연구 유형
등록 (실제)
단계
- 4단계
연락처 및 위치
연구 장소
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São Paulo, 브라질, 04024-003
- Hospital São Paulo - Universidade Federal de São Paulo
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- age over than 18 years old,
- norepinephrine drug use for at least 12 hours and for less than 72 hours,
- sedation level equal or deeper than Ramsay 4,
- blood pressure stable for the last 30 minutes prior to inclusion,
- central venous catheter in place and
- signed informed consent.
Exclusion Criteria:
- pregnancy,
- cirrhosis,
- systemic sclerosis, and
- need to maintain mean arterial pressure above 65mmHg for others conditions
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Norepinephrine
Noradrenaline continuous infusion IV
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Increase in mean arterial pressure using norepinephrine
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Microcirculatory flow index (MIF) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine
기간: after 20 min
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MIF will be measured in points varying from 0 to 4
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after 20 min
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Total vascular density (TVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine
기간: after 20 min
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TVD will be measured in mm/mm2
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after 20 min
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Perfused vascular density (PVD) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine
기간: after 20 min
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PVD will be measured in mm/mm2
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after 20 min
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Proportional perfused vessels (PPV) measured by sidestream darkfield after rising the mean arterial pressure with norepinephrine
기간: after 20 min
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PPV will be measured in percentage
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after 20 min
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공동 작업자 및 조사자
수사관
- 연구 의자: Flavia Machado, PhD, Federal University of São Paulo
간행물 및 유용한 링크
일반 간행물
- Dubin A, Pozo MO, Casabella CA, Palizas F Jr, Murias G, Moseinco MC, Kanoore Edul VS, Palizas F, Estenssoro E, Ince C. Increasing arterial blood pressure with norepinephrine does not improve microcirculatory blood flow: a prospective study. Crit Care. 2009;13(3):R92. doi: 10.1186/cc7922. Epub 2009 Jun 17.
- Leone M, Asfar P, Radermacher P, Vincent JL, Martin C. Optimizing mean arterial pressure in septic shock: a critical reappraisal of the literature. Crit Care. 2015 Mar 10;19(1):101. doi: 10.1186/s13054-015-0794-z.
- Correa TD, Vuda M, Takala J, Djafarzadeh S, Silva E, Jakob SM. Increasing mean arterial blood pressure in sepsis: effects on fluid balance, vasopressor load and renal function. Crit Care. 2013 Jan 30;17(1):R21. doi: 10.1186/cc12495.
- Xu JY, Ma SQ, Pan C, He HL, Cai SX, Hu SL, Liu AR, Liu L, Huang YZ, Guo FM, Yang Y, Qiu HB. A high mean arterial pressure target is associated with improved microcirculation in septic shock patients with previous hypertension: a prospective open label study. Crit Care. 2015 Mar 30;19(1):130. doi: 10.1186/s13054-015-0866-0.
- Fiorese Coimbra KT, de Freitas FGR, Bafi AT, Pinheiro TT, Nunes NF, de Azevedo LCP, Machado FR. Effect of Increasing Blood Pressure With Noradrenaline on the Microcirculation of Patients With Septic Shock and Previous Arterial Hypertension. Crit Care Med. 2019 Aug;47(8):1033-1040. doi: 10.1097/CCM.0000000000003795.
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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- CEP173.166
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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. .
패혈성 쇼크에 대한 임상 시험
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Centre Hospitalier Universitaire Dijon모병Norepinephrine-retractory vasoplegic shock 환자프랑스
norepinephrine에 대한 임상 시험
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Xuanwu Hospital, Beijing아직 모집하지 않음