跳至主要内容
临床试验/CTRI/2022/08/044946
CTRI/2022/08/044946进行中(未招募)不适用

Retrospective observational trial of intraoperative fluid management practice in elective cancer surgery

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2022年1月9日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,000
试验地点
1
主要终点
Intraoperative IV fluid volume in ml / ideal body weight / hr and type of IV fluids used in different types of surgery.

研究概览

简要总结

Background:

Traditionally, intraoperative fluid administration followed a liberal approach in order to counteract starvation deficits and ‘third space’ losses. However, the concept of ‘third space’ has been challenged. Thus routine infusions of large volumes of intravenous fluid intraoperatively can lead to fluid overload leading to tissue oedema. This in turn increases the oxygen transfer distance, thereby increasing the risk of poor surgical-site healing and postoperative complications such as anastomotic leak and a prolonged length of hospital stay (LOS). Restrictive fluid regimens often aim for a low or zero net fluid balance and restrictive protocols often recommend use of vasopressors to maintain blood pressure. However intraoperative hypovolemia and inappropriate use of vasopressors could increase the risk of tissue hypo perfusion leading to organ dysfunction. Recent studies have shown increased risk of acute kidney injury.

Cardiac output monitoring with stroke volume optimisation has been commonly used in goal directed therapy studies in recent years.

Optimal preoperative fluid administration in cancer surgery is a challenging clinical problem as cancer surgery often involves extensive dissection, lymph node clearance and blood loss. This along with systemic inflammatory response causes significant fluid shifts and complicates fluid management.

Thus in the current scenario though liberal fluid is discouraged, it is still unclear as to how much fluid administration should be considered as standard as different studies have used different fluid administration rates. This retrospective observational study is aimed at understanding our current intraoperative fluid management practice in elective cancer surgery and its effect on the intraoperative and post operative course in terms of major complications. This data will help us understand of fluid management strategies across surgical specialties and focus studies on particular aspect of fluid management.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • All adult patients undergoing elective cancer surgery.

排除标准

  • Patients with blood loss more than 1 litre.

结局指标

主要结局

Intraoperative IV fluid volume in ml / ideal body weight / hr and type of IV fluids used in different types of surgery.

时间窗: 12 hours

次要结局

  • 2. In hospital complications will include - Anastomotic dehiscence, ICU /RR stay 48 hrs, sepsis, ICU readmission, re surgery or organ dysfunction. Cardiovascular complications will be defined as any haemodynamic abnormality requiring intervention, need for mechanical ventilation, acute kidney injury, Respiratory complications will be defined as need for mechanical ventilation including HFNC or NIV. CNS dysfunction and liver dysfunction will also be noted(30 days)
  • 1. Intraoperative complications such as need for vasopressor therapy, need for mechanical ventilation at the end of surgery or side effects of colloids.(30 days)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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