Study of Subcutaneous Interstitial Pressure During Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Value of Initial subcutaneous interstitial pressure
研究概览
简要总结
The pathophysiology of sepsis is characterized by the sudden onset of vasodilation and vascular permeability with capillary leakage. This leakage contributes to the development of generalized edema which is not clinically detectable below 4 litres but which becomes visible after a few days. The edema accumulates mainly at the subcutaneous level due to the high compliance of this tissue. Edema, and therefore hydrosodium overload, testifies to the severity of the inflammation. However, it could also be harmful in itself (affecting microcirculation and increasing mortality) as suggested by numerous clinical and experimental studies.
The transfer of fluids between vascular and interstitial compartments during sepsis therefore has a central role in the pathophysiology of the disease and associated mortality. These transfers are mainly controlled at the microvascular level (with constant permeability) by the difference between capillary (CP) and interstitial (IP) pressures. In healthy subjects, subcutaneous IP is discreetly negative (-1 mmHg) and varies very little. On the other hand, a sometimes drastic decrease in IP has been described in various localized and systemic inflammatory situations. These pressure variations may be explained by the collagen structure of the interstitial tissue and a change in the three-dimensional conformation of these macromolecules induced by inflammation mediators. In an animal model of sepsis, a study showed significantly lower pressure in a group of animals in endotoxic shock. IP has never been measured in humans during sepsis. The objective of this study is to analyze subcutaneous IP (SCIP) in patients with septic shock compared with controls in order to evaluate the direct role of interstitial tissue in the onset of edema during sepsis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •Criteria common to both groups:
- •Admitted within the last 24 hours in intensive care,
- •Under mechanical ventilation with orotracheal intubation,
- •Without clinically detectable edema (in any area)
- •Patient and/or guardian and/or close relative has given written consent
- •Patients included in the "septic shock" arm:
- •Diagnosis of septic shock as defined by the "Sepsis-3" Consensus Conference (JAMA 2016) (34): documented or highly suspected infection with SOFA ≥ 2, persistent hypotension after correction of hypovolemia requiring vasopressor administration, and serum lactate > 2 mmol/l.
- •Vascular filling < 50 ml/kg
- •Patients included in the control arm:
- •Absence of sepsis and shock from any cause:
- •PAS > 100 mmHg
- •Absence of vasopressors
- •Preserved urine > 0.5 ml/kg/h
- •Normal serum lactate
- •Crystalloid infusions < 50ml/kg over the previous 12 hours
排除标准
- •not affiliated to national health insurance
- •under court protection
- •pregnant or breastfeeding
- •Clinical disseminated intravascular coagulation (DIC) with hemorrhagic syndrome
- •Admitted after resuscitation for cardiac arrest
- •Presenting cardiogenic shock
- •Presenting acute pancreatitis
- •Severe overall dehydration (clinical signs of dehydration and natremia > 150mmol/l)
- •Presenting metformin intoxication
- •In severe sepsis or septic shock for more than 24 hours,
- •Dying or for whom death seems imminent (within 24 hours),
- •Hypersensitivity to lidocaine and/or prilocaine or local anesthetics of the amide type or to any of the excipients of EMLAPATCH®
研究组 & 干预措施
Septic shock
干预措施: Subcutaneous pressure measurement (Procedure)
Control
干预措施: Subcutaneous pressure measurement (Procedure)
结局指标
主要结局
Value of Initial subcutaneous interstitial pressure
时间窗: Day 0
Measure the difference between the subcutaneous interstitial pressure of patients in septic shock compared to patients without sepsis
次要结局
未报告次要终点