Effects of Fluid Therapy on Peripheral TIssue Perfusion During Sepsis/Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
研究概览
简要总结
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
详细描述
This is a transversal study allowing to compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion
Design:
• A multicentric, open-label, transversal study
Sample size :
60 patients
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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 old
- •Sepsis or
- •Septic shock within 24 hours of admission to intensive care with a stable dose of norepinephrine for at least 2 hours to maintain MAP> 65mmHg
- •CRT index> 3 seconds despite the initial resuscitation (administration of antibiotics, volume expansion by crystalloids of 20 mL / Kg, noradrenaline started) between the admission to intensive care and H48 from admission to intensive care
- •Non-opposition of the patient collected by the doctor in charge of the patient between H0 and H6 after admission if the patient is vigilant, otherwise a procedure for collecting non-opposition from relatives will be carried out with collection of the non-opposition of the patient once he is able to give it.
- •Affiliation to a social security regimen (excluding AME)
排除标准
- •Patient COVID-19 (+) with respiratory impairment
- •Pregnant and lactating woman
- •Patient under Guardianship / Curatorship
- •Refusal to participate
- •CRT not evaluable (dark or damaged skin)
- •Moribund patient
- •Estimated life expectancy less than 1 month
- •Participation in another interventional research involving the human person or period of exclusion at the end of a previous research involving the human person
结局指标
主要结局
Compare the effect of volume expansion by saline versus albumin on the correction of peripheral tissue hypoperfusion by measuring Index skin recoloration time (CRT) at H0 and H1
时间窗: 1 hour
Proportion of patients who normalized their cutaneous re-coloring time (CRT) measured at the index level, defined by a value \<3 seconds at H1. The clinical measurement method has been standardized in the participating departments and has been used for several years in clinical practice.
次要结局
- Diuresis(4 hours)
- mottling score measure(4 hours)
- Variations in cardiac flow(4 hours)
- Variations in the biological parameters(4 hours)
- CRT Measure(4 hours)