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临床试验/NCT07330908
NCT07330908已完成不适用

Impact of Different Norepinephrine Doses on Accuracy of Peripheral Perfusion Index in Predicting Tissue Perfusion in Septic Shock Patients

Tanta University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月30日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Correlation between Peripheral Perfusion Index and ( Central venous oxygen saturation , and lactate clearance).

研究概览

简要总结

This study aims to evaluate the impact of different norepinephrine doses on the accuracy of the peripheral perfusion index in predicting tissue perfusion in septic shock patients.

Primary outcome:

  • Correlation between peripheral perfusion index

Secondary outcomes:

  • Peripheral perfusion index accuracy to predict the tissue perfusion .
  • Peripheral perfusion index accuracy to predict mortality.

详细描述

Septic shock is a common cause of intensive care unit admission and one of the major causes of death among intensive care unit inpatients.

It is a complex critical condition associated with a reported mortality rate of up to 30% to 40%.

. It is the most severe form of sepsis with concomitant hemodynamic failure and immune, inflammatory, and metabolic disorders. The resulting circulatory shock finally leads to an alteration of tissue perfusion, causing organ failures and associated poor outcomes.

An essential step in managing patients with septic shock is to increase systemic and regional/microcirculatory flow. Increasing arterial blood pressure with vasopressors when patients are hypotensive improves the input pressure that drives organ perfusion. Therefore, maintaining organ perfusion in the time course of septic shock is a fundamental goal.

Norepinephrine is a commonly used vasopressor in the management of septic shock. It increases vascular tone and blood pressure, thereby improving systemic perfusion. However, excessive norepinephrine dosing is associated with the risk of extreme vasoconstriction, tissue hypoperfusion, and increased mortality. Peripheral and regional tissue perfusion in patients with septic shock have been extensively studied over the last decade. Indeed, several authors have emphasized the potential benefits of monitoring microcirculatory and regional perfusion parameters to better guide the resuscitation of these patients and give a prognosis. The peripheral perfusion index ,which is defined as the ratio of the pulsatile to non-pulsatile component of the pulse oximetry plethysmograph (peripheral perfusion index = pulsatile signal/ non-pulsatile signal), is used as a simple and accurate indicator of the pulsation intensity of peripheral arterioles .

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 to 65 years.
  • Both sexes.
  • Septic shock patients requiring norepinephrine infusion at dose <0.25 µg/kg/min to achieve mean arterial pressure (Mean arterial blood pressure ≥ 65 mm Hg).

排除标准

  • Patients fail to achieve Mean arterial blood ≥ 65 mm Hg or need norepinephrine dose ≥0.25 µg /kg/min.
  • Pregnancy.
  • Diabetes mellitus.
  • Tissue edema.
  • Respiratory diseases affecting gas exchange, such as asthma and Chronic Obstructive Pulmonary Disease.
  • Sever hypoxemia or hypercarbia.
  • Core temperature < 36 ᴼc.
  • Body mass index ≥35 kg/m2
  • Cardiovascular diseases and pulmonary edema

研究组 & 干预措施

Group I

Experimental

Patients will receive norepinephrine <0.15 µg/kg/minute

干预措施: Group I: Patients will receive norepinephrine <0.15 µg/kg/min (Drug)

Group II

Experimental

Patients will receive norepinephrine ≥ 0.15 µg/kg/minutes

干预措施: Group II: Patients will receive norepinephrine ≥ 0.15 µg/kg/min (Drug)

结局指标

主要结局

Correlation between Peripheral Perfusion Index and ( Central venous oxygen saturation , and lactate clearance).

时间窗: Before initiation of vasopressor therapy, 5 minutes, 30 minutes, 1 hour, 2 hours, and 6 hours post-initiation of vasopressor therapy

次要结局

  • Mean arterial blood pressure(Before the initiation of vasopressor therapy, 5 minutes, 30 minutes,, 1 hour, 2 hours, and 6 hours after the initiation of vasopressor therapy.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Alaa Abdelghafar Elbaghdady

Resident

Tanta University

研究点 (1)

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