Intra-operative Hypotension and Post-operative Lactate Level After Pancreatic-duodenectomy. A Prospective Multicenter Observational Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- hypotensive events
研究概览
简要总结
Intraoperative hypotension is a frequent occurrence during pancreaticoduodenectomy (PD) and has been associated with impaired tissue perfusion and organ dysfunction. However, its specific relationship with early postoperative hyperlactatemia and clinical outcomes inpancreaticoduodenectomy (PD) patients remains poorly characterized.
Identifying a correlation between time-weighted average hypotension (TWA65) and postoperative lactate levels could provide valuable insights for optimizing intraoperative hemodynamic management and improving postoperative outcomes in high-risk abdominal surgery.
详细描述
The primary objective of the study is to evaluate the association between intraoperative hypotension, defined as time-weighted average hypotension TWA65 > 0.2 mmHg, and postoperative lactate levels (>2 mmol/L at at time of arrival (RR0) and after 1 hour (RR1), as well as lactate clearance. Secondary objectives include assessing the relationship between hyperlactatemia (>4 mmol/L), impaired lactate clearance (Lacclear < 0), and the incidence of postoperative complications. The study also investigates how intraoperative factors such as fluid balance, body temperature, duration of surgery, cardiac index (CI), and cardiac power index (CPI) affect lactate levels and clearance. The primary endpoints are postoperative lactate levels and lactate clearance, while secondary endpoints include hyperlactatemia, lactate clearance deficit, and their association with clinical outcomes.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 80 years
- •Undergoing open pancreaticoduodenectomy (DCP)
排除标准
- •Age under 18 or over 85 years
- •Severe cardiac disease classified as NYHA (New York Heart Association) class III-IV
- •Cirrhotic liver disease
- •Pregnancy
- •Puerperium or breastfeeding
- •ASA (American Society of Anesthesiologists) physical status score greater than 3
研究组 & 干预措施
patients undergoing pancreatic duodenectomy
结局指标
主要结局
hypotensive events
时间窗: 1 hour post operative
The primary objective of the study is to evaluate the association between intraoperative hypotension, defined as Time-Weighted Average of intraoperative hypotension (TWA65) \> 0.2 mmHg, and postoperative lactate levels (\>2 mmol/L at RR0 and RR1 (at time of arrival (RR0) and after 1 hour (RR1), as well as lactate clearance.
次要结局
- serum lactate(7 days)
研究者
Michele Tedeschi
Medical Doctor
Istituto Clinico Humanitas