Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Delta lactate
研究概览
简要总结
This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Adults > 18 years
- •Severe sepsis* as defined by the ACCCP/SCCM consensus conference
- •Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min (in and out patients).
排除标准
- •Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC
- •Neurotrauma (Glasgow Coma Score < 12) and/ or medullar trauma
- •Known pregnancy or diagnosed by US or Ct-scan (> 14 weeks)
- •Sustained cardiac arrhythmia (see Logbook P8)
- •Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)
- •Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)
- •Burn injury > 10%
- •Needed emergency thoracotomy or ABC resuscitation protocol
- •Pre-existing severe liver dysfunction(Child-Pugh class C)
- •Do-not-resuscitate order, died within 48h of admission
研究组 & 干预措施
CONTROL
In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
At the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary.
干预措施: CONTROL (Other)
OPTIMIZED
In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).
The administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).
干预措施: OPTIMIZED (Other)
结局指标
主要结局
Delta lactate
时间窗: From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.
The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (∆ lactate).
次要结局
- Cardiovascular complications: myocardial infarct or congestive heart failure(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first)
- Cerebral complications: stroke(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Pulmonary complications: ALI/ARDS, bronchopneumonia(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Pulmonary complications: respiratory insufficiency necessitating re-intubation(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Surgical complications: re-operation for bleeding or infection(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Renal complications: infection, urosepsis or renal insufficiency(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first)
- Duration of post-operative mechanical ventilation: in hours(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Total duration of ventilation : days(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first)
- Length of stay in the ICU: in days(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Length of stay in hospital: in days(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.)
- Mortality(From randomization up to 28 days)
- SOFA score measurement(From randomization : day 1, day 2, day 3)
- Death(Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first)
- Number of unexpected ICU admission(From randomization up to 28 days)
研究者
Pavlovic Gordana, MD
Principal Investigator
University Hospital, Geneva