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临床试验/NCT04474431
NCT04474431已完成不适用

Correlation of VEGF-A and Fluid Balance in Septic Shock

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 103 人开始时间: 2019年12月24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
发起方
入组人数
103
试验地点
1
主要终点
Show that elevation of VEGF-A levels at D1 in the management of patients with septic shock is positively correlated with a positive fluid balance.

研究概览

简要总结

VEGF is a key molecule in the control of vascular permeability via interactions with the VEGF-receptor on the endothelial cell. Several authors reported plasma VEGF levels are elevated in sepsis shock and associated with increased mortality (1,2).

In septic shock, the main elements of treatment are intravenous fluids, appropriate antibiotics and vasopressors. Some authors observed positive fluid balance is associated with increased mortality rates in patients (3,4).

To the best of our knowledge, no studies have shown a correlation between VEGF levels and the fluid balance. The aim of our study was to determine the role of VEGF in capillary leakage and the positive fluid balance in septic shock.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •Patient above 18 years old
  • •Patient with septic shock (presence of an infection, hypotension with mean arterial pressure less than 65mmHg and the need for vasopressor treatment (minimum dose 0,3µ/kg/min)
  • •Person informed and signed consent.

排除标准

  • •Death predicted within 24 hours
  • •Limitation of therapeutic attitudes
  • •Treatment with bevacizumab in the past 6 months
  • •Pathologies with endothelial dysfunction (scleroderma, clarkson syndrome...)
  • •Acute renal failure (KDIGO 3) at ICU admission defined by :
  • •Increase in serum creatinine to > 354µmol/l or 3 times baseline OR
  • •Urine output ≤0,3 ml/kg/h for 24h OR
  • •Anuria for 12h
  • •Morbid obesity with a body mass index (BMI) > 35 kg/m².
  • •Limb amputation
  • •Morbid obesity with a body mass index (BMI) > 35 kg/m².
  • •Amputation of a limb
  • •Pregnant or nursing women
  • •Inability to obtain consent from family
  • •Person with guardianship or curatorship

研究组 & 干预措施

Patients admitted in the ICU of hospital of Rouen

Other

Patients admitted in the intensive care unit (ICU) of the teaching hospital of Rouen.

干预措施: Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance. (Other)

结局指标

主要结局

Show that elevation of VEGF-A levels at D1 in the management of patients with septic shock is positively correlated with a positive fluid balance.

时间窗: 1 day

Plasma assay of the VEGF-A by enzyme-linked immunosorbent assay (ELISA) and calculated fluid balance at D1 of ICU admission.

次要结局

  • Correlation of VEGF A levels at D1 and mortality at D28 of management.(28 days)
  • Evolution of VEGF A and sFLT1 levels between D1 and D3 of ICU admission.(1 and 3 days)
  • Correlation of VEGF-A levels and fluid balance at D3 of ICU admission.(3 days)
  • Correlation of VEGF-A levels with edema at D1 and D3 of ICU admission.(1 and 3 days)
  • Correlation of Soluble Vascular Endothelial Growth Factor Receptor 1 (sFlt1) levels and edema at D1 and D3 of ICU admission.(1 and 3 days)
  • Correlation of VEGF A levels and microcirculation at D1 and D3 of ICU(1 and 3 days)
  • Correlation of sFlt1 levels and fluid balance at D1 and D3 of ICU admission.(1 and 3 days)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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