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临床试验/NCT05902273
NCT05902273已完成不适用

The Value of Peripheral Arterial Resistive Index in Evaluation of Tissue Perfusion in Patients With Septic Shock

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
correlation of snuffbox radial artery resistive index and systemic vascular resistance index

研究概览

简要总结

In patients with septic shock, routine arterial blood pressure and central venous pressure are monitored in ICU. Conventional methods such as blood pressure and central venous pressure in septic patients cannot provide sufficient information in the follow-up due to the body's compensation mechanisms. The systemic vascular resistance index, which can be measured invasively or non-invasively with advanced hemodynamic monitoring methods, is a parameter that plays an important role in the management of septic patients.

Resistive index (Pourcelot Index) is an ultrasonic measurement method used to evaluate tissue perfusion and microcirculation. Since peripheral tissue perfusion is impaired in septic patients, the investigators think resistive index may be useful for management of sepsis. There are studies in the literature on the use of resistive index in the follow-up of patients.

The study will be about whether there is a correlation between the systemic vascular resistance index measured by cardiac output measurement, which is one of the advanced monitoring methods routinely used in the group requiring mechanical ventilation support in patients with septic shock, and the peripheral arterial resistive index, which is routinely used to evaluate tissue perfusion and microcirculation.

详细描述

Sepsis is not a specific disease but abnormal response for infection, leading to organ dysfunction. It is a clinical syndrome consisting of biological, biochemical, and physiological abnormalities which pathophysiology has not yet been fully determined. Sepsis is shaped by pathogenic factors and host factors (eg, gender, race and other genetic determinants, age, comorbidities, environment) and its features evolve over time. What distinguishes sepsis from infection is the presence of abnormal and/or irregular host response and organ dysfunction. It is one of the leading health problems worldwide and one of the leading causes of mortality in hospitalizations. Its estimated that there were 48.9 million cases and 11 million sepsis-related deaths worldwide in 2017, accounting for almost 20% of all global deaths. In an epidemiological study conducted in European intensive care units (ICU), the incidence of sepsis was reported as 38%. Pneumonia, urinary tract, and intra-abdominal infections account for more than 65% of all sepsis cases. According to the Surviving Sepsis Campaign (SSC) data, mortality rates in sepsis are 41% in Europe and 28.3% in the United States (USA). In a multicenter study involving 101,064 critically ill patients in Australia and New Zealand between 2002 and 2012, mortality rates due to sepsis were found to decrease over the years and finally to 18-20%. Recognition of sepsis, which can be very mortal, especially if not recognized fast and treatment not started, requires urgent attention.

Due to the lack of treatment options targeting microcirculatory and mitochondrial dysfunction, treatment has been focused on correcting the macrocirculatory dysfunction in addition to treating the underlying cause during septic shock. In the early phase of septic shock, external losses and hypovolemia are seen because of capillary leakage. Therefore, fluid resuscitation is often recommended to increase cardiac output and improve tissue perfusion. However, large boluses of fluids (>30 ml/kg) do not reliably increase blood pressure, urine output, and end-organ perfusion, and may lead to iatrogenic damage. Sepsis is characterized by disruptions in tissue perfusion and abnormal peripheral vascular resistance, because of disruptions in microcirculation. therefore, improving vascular function and organ damage is crucial in the management of septic shock. For treatment of hypotension; the need for fluid should be determined and the right amount of fluid resuscitation should be provided to the right patient.

Systemic vascular resistance is a parameter that depends on the afterload of the heart and corresponds to the resistance of the heart while it is working. It is the resistance the heart has to overcome to pump blood to the rest of the body except the lungs. The systemic vascular resistance index (SVRI) is defined as the ratio of mean arterial pressure (MAP) and central venous pressure (CVP) to cardiac index (CI) (SVRI= 80 x (MAP-CVP) / CI). In general, SVRI is proportional to MAP. It decreases due to vasodilation in septic patients. Compared to previous studies, lower SVRI in septic shock was associated with adverse outcomes and increased mortality. Invasive methods such as pulmonary artery catheters or relatively expensive methods such as PICCO are required for SVRI measurement.

Can a more cost-effective and rapid alternative to the systemic vascular resistance index measured by expensive or high-risk methods be found? Ultrasound, as modern stethoscope, is a need especially in every 3 level ICU.

The resistive index (RI) (Pourcelot index) is a noninvasive measurement used to evaluate vessel compliance with Doppler ultrasound. It is determined by a formula calculated between the systolic peak flow rate (PSV) and the end-diastolic flow rate (EDV) ((PSV-EDV)/PSV). Today RI is using for measure to assess tissue perfusion, particularly on the kidney. Renal RI shows changes in renal intravascular volume and hemodynamics. An inverse relationship has been shown between renal RI and MAP in acute kidney injury. Measurement of RI on the peripheral artery correlated with SVRI in a study of patients who had undergone cardiac surgery.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years old
  • admitted to intensive care for septic shock
  • mechanical ventilated
  • non spontaneous breathing
  • applied invasive artery cannulation (radial, femoral, brachial)
  • applied central venous catheter (jugular, subclavian)
  • SOFA score>2
  • Receiving vasopressor/inotrope support to achieve MAP ≥65 mmHg
  • Blood lactate >2mmol/L

排除标准

  • <18 years old
  • Hypothermia (<35C)
  • Atrial fibrilation/flutter
  • Pace-maker
  • Severe aort valve insufficiency
  • History of aortic and the great arteries adjacent to the aortic arch surgery
  • Bilateral radial artery puncture in last 12 hours
  • Peripheral artery disease
  • Extremity amputation (leg or arm)
  • Wound on forearm
  • Continous Renal Replacement Therapy
  • Spontaneous breath effort

结局指标

主要结局

correlation of snuffbox radial artery resistive index and systemic vascular resistance index

时间窗: 1 hour. As soon as patient meets all of the inclusion criteria

correlation of snuffbox radial artery resistive index and systemic vascular resistance index

次要结局

  • correlation of snuffbox radial artery resistive index and delta stroke volume index(1 hour. As soon as patient meets all of the inclusion criteria)
  • correlation of snuffbox radial artery resistive index and diastolic shock index(1 hour. As soon as patient meets all of the inclusion criteria)
  • correlation of snuffbox radial artery resistive index and pleth variability index(1 hour. As soon as patient meets all of the inclusion criteria)
  • correlation of snuffbox radial artery resistive index and cardiac power index(1 hour. As soon as patient meets all of the inclusion criteria)
  • correlation of snuffbox radial artery resistive index and central vena cava oxygen saturation and partial carbon dioxide pressure gap(1 hour. As soon as patient meets all of the inclusion criteria)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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