Peripheral Perfusion Index Trajectory as a Predictor of 28-Day Mortality and Its Incremental Value Over SOFA and Lactate in Patients With Sepsis and Septic Shock: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- All-cause mortality at 28 days
研究概览
简要总结
Sepsis is a life-threatening condition caused by the body's overwhelming response to infection, and it remains a leading cause of death in intensive care units. Even when standard treatment targets such as blood pressure are met, blood flow to the small vessels of the skin and other tissues may remain impaired. This "hidden" poor perfusion may not be detected by routine monitoring, yet it may be linked to worse outcomes.
The perfusion index is a simple number obtained from the standard pulse oximeter already placed on a patient's finger. It reflects blood flow in the peripheral tissues, requires no additional procedure, and causes no discomfort.
This prospective observational cohort study will examine whether the perfusion index, and especially how it changes over the first 24 hours in the intensive care unit, can help predict death within 28 days in adults with sepsis or septic shock. Capillary refill time and skin mottling score will be recorded as additional bedside measures of peripheral perfusion.
No treatment will be changed for the purpose of this study, and no additional blood samples or invasive procedures will be performed. All care decisions remain with the treating team. Measurements will be taken at intensive care admission and at 6 and 24 hours. Participants will be followed for 28 days, with survival status also recorded at 90 days.
The study will be conducted at two centers. A prediction model will be developed in the first center and then tested, without modification, in patients enrolled at the second center.
详细描述
Background and rationale
Sepsis and septic shock remain leading causes of intensive care unit (ICU) mortality. Resuscitation is commonly guided by macrohemodynamic targets such as mean arterial pressure (MAP), urine output, and lactate clearance. However, restoration of macrocirculatory targets does not guarantee adequate microcirculatory perfusion. This macro-micro discordance, sometimes referred to as occult or hidden hypoperfusion, has been associated with progressive organ dysfunction and worse outcomes, yet it is not captured by routine monitoring.
The peripheral perfusion index (PI) is derived from the standard pulse oximetry waveform and represents the ratio of pulsatile to non-pulsatile signal. It is continuous, non-invasive, requires no additional equipment beyond routine monitoring, and reflects peripheral perfusion. Most available evidence has evaluated PI at a single time point, which may not capture the dynamic nature of resuscitation. Whether the trajectory of PI over the first 24 hours provides prognostic information beyond established severity scores has not been adequately established.
Objectives
Primary objective: to determine whether the trajectory of the peripheral perfusion index during the first 24 hours of ICU admission independently predicts 28-day all-cause mortality in adults with sepsis or septic shock.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Diagnosis of sepsis or septic shock according to Sepsis-3 criteria (suspected or confirmed infection with an acute increase in SOFA score of 2 points or more)
- •Enrollment possible within the first 6 hours of intensive care unit admission
- •Written informed consent obtained from the patient or, when the patient lacks decision-making capacity, from a legal representative, in accordance with the approved consent procedure
排除标准
- •Conditions precluding valid peripheral perfusion measurement at both measurement sites, including severe peripheral arterial disease, limb ischemia or amputation, extensive edema or burns, or local trauma at the measurement site
- •Intensive care unit stay of 24 hours or longer at another facility prior to admission
- •Decision to withdraw or limit life-sustaining treatment planned within the first 24 hours
- •Pregnancy
- •Severe Raynaud phenomenon or vasospastic disease of the extremities
- •Persistent tremor or agitation precluding standardized measurement
- •Concurrent enrollment in an interventional study
结局指标
主要结局
All-cause mortality at 28 days
时间窗: 28 days from ICU admission
Proportion of patients who die from any cause within 28 days of ICU admission. Vital status is ascertained through direct clinical follow-up during hospitalization and, for patients discharged before day 28, through hospital records or telephone contact.
次要结局
- All-cause mortality in the intensive care unit(From ICU admission to ICU discharge, up to 90 days)
- All-cause in-hospital mortality(From ICU admission to hospital discharge, up to 90 days)
- All-cause mortality at 90 days(90 days from ICU admission)
- Vasopressor-free days at day 28(28 days from ICU admission)
- Duration of invasive mechanical ventilation(From ICU admission to ICU discharge, up to 28 days)
- Development of new organ failure(7 days from ICU admission)
- Shock reversal(28 days from ICU admission)
- Intensive care unit length of stay(From ICU admission to ICU discharge, up to 90 days)
- Hospital length of stay(From hospital admission to hospital discharge, up to 90 days)
研究者
Faruk Yildız
Intensive Care Medicine Fellow, Division of Intensive Care Medicine
Trakya University