NCT01653977终止不适用
Impact of Early Goal-directed Fluid Therapy in Hypovolemic Patients Undergoing Emergency Surgery A Prospective, Randomised, Open Trial
适应症
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 compares the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in trauma patients requiring emergency surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 hypovolemic condition°
- •Need for emergent interventional procedure under general anesthesia with an expected duration > 120 min.
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
- •Ultra-emergent surgery with no further diagnostic investigation.
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.)
- 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.)
- 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.)
- 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.)
- Death(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)
- Number of unexpected ICU admission(From randomization up to 28 days)
研究者
Pavlovic Gordana, MD
Principal Investigator
University Hospital, Geneva
研究点 (2)
Loading locations...
相似试验
终止
不适用
Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency SurgerySevere SepsisEmergencySurgeryNCT01654003University Hospital, Geneva20
招募中
不适用
Fluid therapy in plastic surgeryIRCT20210508051226N1Tehran University of Medical Sciences72
已完成
不适用
Effect of Goal-directed Fluid Therapy on Postoperative ComplicationsLiver DiseasesPancreas DiseaseNCT03169998Seoul National University Bundang Hospital375
Unknown
不适用
Preoperative Goal-directed Fluid Therapy and Physiological Changes Following One-lung VentilationTherapy Adverse EffectNCT03064880National Taiwan University Hospital60
招募中
不适用
GDFT on the Postoperative Outcome in Head and Neck Cancer SurgeryPostoperative ComplicationsNCT06468852Beijing Tongren Hospital340