Extracorporeal Cytokine Removal in Patients With Septic Shock in an Adult Intensive Care Unit
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- changes in norepinephrine requirements meassured in micrograms/kg/ min ( gamma) before and after hemoperfusion (HP) treatment.
研究概览
简要总结
Goals Primary: compare changes in norepinephrine requirements before and after hemoperfusion (HP) treatment.
Secondary: demonstrate the decrease in levels of IL-6 , assess the total and individual change of SEQUENTIAL ORGAN FAILURE ASSESSMENT (SOFA), establish the resolution of shock , clearance of lactate , and mortality at discharge from INTENSIVE CARE UNIT (ICU), at 30 and 60 days.
详细描述
The study will take place at UTI Dr. José María Cullen Hospital in the city of Santa Fe. An observational study will be carried out in adult patients with septic shock (according to the definition of Sepsis-3), presenting hypotension, requiring vasopressors to maintain a mean arterial pressure (MAP) of 65 mmHg, blood lactate> 2 mmol / L, after adequate resuscitation with fluids and in need of extracorporeal membrane oxygenation (Extracorporeal Membrane Oxygenation, ECMO), Renal Replacement Therapy (TRR) ( which may be continuous (Continuous Renal Replacement Therapy (CRRT)) or Extended Slow Daily Dialysis (SLEDD) or both, added to the hemoperfusion (HP) treatment.
The study was designed by the authors, without receiving any input from companies.
Patients will be treated according to The Surviving Sepsis Campaign 2016 recommendations: identification and control of the infectious focus (surgery). It will begin with antibiotics as soon as possible, resuscitation with crystalloids at 30 mL / kg in case of hypotension and continue according to assessment of dynamic and static parameters (EV 1000, Swan Ganz, central venous pressure and echocardiography, used at the discretion of attending physician). Noradrenaline will be administered to maintain a MAP ≧ 65 mmHg. Dobutamine will be indicated if the minute volume <3.0 L / min / m2. According to our practice, adrenaline will be added if the dose of norepinephrine exceeds 2 μg / kg / min. In addition, 100 mg of hydrocortisone will be administered every 8 hours.
In case of requiring TRR for AKI, continuous vein-venous hemodiafiltration will be started using Prismaflex or Amplya equipment with a dose of 35 mL / kg / h, at a 1: 1 ratio, the replacement solution / dialysate solution, with AN ST 1.5 filter, HF 1.4 or HFT 1.4 or 1.7 or 2.2 with citrate as an anticoagulation method. In the case of ECMO, anticoagulation will be performed with heparin, according to the standardized practice of the service.
Treatment with HA 330 cartridges: Hemoperfusion treatment will be initiated as soon as possible, no later than 12 hours after the diagnosis of septic shock. An 8-hour treatment will be indicated for 2 (two) consecutive days. Prior to using the cartridge, 12,500 units of sodium heparin will be placed inside through the hole located in the upper region. During the next 30 minutes, it will be necessary to rotate it so that heparin is distributed throughout its interior. After 30 minutes, a physiological solution should be washed (a total of 2000 mL, with an infusion pump or by gravity pump) in order to remove the heparin, and in turn, avoid the formation of bubbles or air accumulation. After this step it is ready to be used, either for isolated HP therapies or in association with other therapies (SLEDD, ECMO, CRRT )
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.> 18 years
- •Diagnosis of septic shock (according to sepsis-3 definition)
- •Dose of norepinephrine ≧ 0.4 μg / kg / min
- •Plasma levels of IL-6> 900 pg / mL
- •Procalcitonin (PCT) ≧ 2 ng / mL
- •Need for renal replacement therapies or ECMO
排除标准
- •Neoplastic disease with or without treatment
- •Pregnant or lactating women (human chorionic gonadotrophin (hCG) test will be performed on potential patients before recruiting for treatment) -
结局指标
主要结局
changes in norepinephrine requirements meassured in micrograms/kg/ min ( gamma) before and after hemoperfusion (HP) treatment.
时间窗: 8 hours
we will meassure norepinephrine requirements by placing arterial monitoring during hemoperfusion procedure
次要结局
- levels of IL-6(8 hours)
- changes of Sequential Organ Failure Assessment ( SOFA)(8 hours)
- concentration of lactate clearence(8 hours)
- mortality at discharge from UTI(7 days; 30 days , 60 days)
研究者
Rafael Avila
Rafael Avila ( PI)
Hospital Jose Maria Cullen
