- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03805321
The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness
The Validity of Peripheral Perfusion Index to Predict Fluid Responsiveness Using Mini-fluid Challenge Test
연구 개요
상태
정황
상세 설명
The concept of fluid responsiveness has been suggested to guide fluid administration in critically ill patients to avoid either over or under-transfusion.
Several methods have been suggested to detect fluid responsiveness. Mini fluid challenge with concomitant monitoring of stroke volume is one of the most robust methods for pre-load challenge.
The main foreshortening of mini fluid challenge method is the need for a real-time cardiac output monitor, to track the instantaneous change of stroke vole with changing body position. Finding a surrogate to cardiac output to trace the effect of mini fluid challenge would make the test more applicable without the need for advanced hemodynamic monitors.
There is a growing interest in the use of perfusion indices in assessment of fluid responsiveness. Perfusion indices are measures for adequacy of oxygen delivery in peripheral tissues; thus, they were hypothesized to be possible surrogates of cardiac output. Peripheral perfusion index represents "the ratio between the pulsatile and non-pulsatile component of the light reaching the pulse oximeter" . Peripheral perfusion index has been considered as a numerical non-invasive measure for peripheral perfusion. PPI has the advantage over other perfusion indices that it a non-invasive, user-friendly monitor.
The aim of this work is to investigate the ability of peripheral perfusion index to predict the hemodynamic response to mini-fluid challenge in patients with septic shock.
Mini-fluid challenge test will be performed by infusion of 200 mL Lactated Ringer's solution over 1 minute. Velocity time integral will be monitored using Transthoracic echocardiography at the left ventricular outflow tract at the apical five-chamber view. Cardiac output will be calculated, and the patient will be considered fluid-responder if cardiac output increased by 10% after fluid challenge.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Cairo, 이집트, 11432
- Ahmed Mohamed Hasanin
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Septic shock patients
Exclusion Criteria:
- Evident blood loss
- Peripheral vascular disorders
- Upper limb injury or burns
공부 계획
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디자인 세부사항
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주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peripheral perfusion index
기간: 2 hours
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It is a number describing the ratio between pulsatile and non-pulsatile blood flow measured by pulse oximeter.
It is measured in percent.
with the best value of 20% and the worst value of 0.1%
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2 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Velocity time integral
기간: 2 hours
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it is a parameter measured from Doppler across the left ventricular outflow tract.
It is calculated by dividing the blood velocity by time and measured in cm
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2 hours
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Mean arterial blood pressure
기간: 2 hours
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Mean arterial blood pressure measured in mmHg
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2 hours
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Central venous pressure
기간: 2 hours
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Central venous pressure measured from a central venous catheter.
It is measured in cmH2o
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2 hours
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Systolic arterial blood pressure
기간: 2 hours
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Systolic arterial blood pressure measured in mmHg
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2 hours
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Diastolic arterial blood pressure
기간: 2 hours
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Diastolic arterial blood pressure measured in mmHg
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2 hours
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Cardiac output
기간: 2 hours
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The amount of blood pumped by the heart in one minute.
it is measured as liters per minute
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2 hours
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공동 작업자 및 조사자
스폰서
수사관
- 연구 책임자: Ahmed Shash, Professor, Head of department of anesthesia, Cairo University, Egypt
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
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. .
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