Comparison Between Goal Directed Therapy and PCO2 Gap Algorithm Application on Outcome of High Risk Surgical Patients Undergoing Major Abdominal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Post operative mortality
研究概览
简要总结
- Primary (main):
Comparison between goal directed therapy and PCO2 gap algorithm (carbon dioxide partial pressure venous arterial gap algorithm) application on 30 days mortality and organ dysfunction post operative 2. Secondary (subsidiary):
Comparison between goal directed therapy and PCO2 gap algorithm application on number of ventilator dependant days, number of days on vasopressors or inotropes length of ICU stay, length of hospital stay,
详细描述
High risk surgical participants in South valley university hospitals (teaching hospitals) who will undergo major abdominal surgeries will be included in research after giving written informed consent from the participants or from the patient's legal representative. The use of obtained data will be approved by local ethics committee.
All participants will be evaluated pre operatively and pre medicated according to protocols in our hospital, base line sequential organ failure (SOFA) score will be taken. General anesthesia for all patients will be carried on according to our local standards. As part of our routine hemodynamic monitoring during major surgery, all patients will be monitored with central venous (standard three-lumen catheter) and arterial catheters placed before the beginning of surgery. The central venous line will be positioned with the tip within the superior vena cava, and correct positioning will be verified by chest radiograph.
the participants will be divided randomly onto to groups using numerical system group A PCO2 gap algorithm(carbon dioxide partial pressure venous arterial gap) will be applied intraoperative and 12 h postoperative end point PCO2 gap 2-6mm Hg(appendix 1).
Group B goal directed therapy protocol which will include targets mean arterial blood pressure ( MAP) > 65 mmHg, central venous pressure(CVP) between 8-12 cmH2O , Haematocrite value more than 30, mixed venous oxygen saturation (Svo2) >75% and urine output more than >0.5 ml/kg/hr and will be applied intraoperative and 12 postoperative end point base deficit +/- 2(appendix 2 ).
All participants will be admitted to the ICU (intensive care unit) immediately after surgery .Standard postoperative monitoring will include: electrocardiograph (heart rate), invasive mean arterial pressure, pulse oxygen saturation and urine output then will be all managed according to their allocated group for 12 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical criteria for high-risk surgical patients used by Shoemaker and colleagues and adapted by Boyd and colleagues
排除标准
- •patients who will refuse to continue on research patients who will not be admitted post operative in the ICU
研究组 & 干预措施
PCO2 gap algorithm
PCO2 gap,haematocrite value,Spo2,cardiac index
干预措施: cv line insertion (Device)
PCO2 gap algorithm
PCO2 gap,haematocrite value,Spo2,cardiac index
干预措施: Urinary catheter insertion (Device)
PCO2 gap algorithm
PCO2 gap,haematocrite value,Spo2,cardiac index
干预措施: Arterial line (Device)
goal directed therapy
svo2,haematocrite value,urine output,mean arterial pressure and central venous pressure
干预措施: cv line insertion (Device)
goal directed therapy
svo2,haematocrite value,urine output,mean arterial pressure and central venous pressure
干预措施: Urinary catheter insertion (Device)
结局指标
主要结局
Post operative mortality
时间窗: 30 days
early post operative mortality
次要结局
- post operative organ failure(30 days)
研究者
Hassan Abdelsapour Abdelrazek
PhD Candidat
South Valley University