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临床试验/CTRI/2024/05/067139
CTRI/2024/05/067139招募中不适用

Prospective observational trial of intraoperative use of vasopressor and inotropic drug infusion in elective cancer surgeries.

Tata memorial Centre Mumbai1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月22日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Number of adult patients undergoing elective cancer surgery requiring intraoperative vasopressor / inotrope infusions

研究概览

简要总结

**Background:**Intraoperative hypotension is common in major oncological surgeries due to factors like hypovolemia, decreased systemic vascular resistance (SVR), and decreased inotropicity. Considering the complications associated with excessive fluid administration ,fluid management strategies have shifted towards conservative fluid therapy . This approach often necessitates the use of vasopressors and/or inotropes to maintain normal blood pressure. A rise in renal injury with restrictive fluid management is highlighted by many recent studies. Balanced fluid therapy, aiming for specific hemodynamic targets, has led to increased use of vasopressors. This study aims to understand the current patterns of intraoperative vasopressor and inotrope usage in elective cancer surgeries and determine the complications in these patients.

**Study Methodology:**All adult patients undergoing elective cancer surgery requiring intraoperative vasopressor or inotrope infusions will be enrolled in this prospective observational trial. Decision regarding vasopressor use will be made by attending anesthesiologists. Data will be collected prospectively from electronic and physical medical records. Revised Cardiac Risk Index will be calculated in all cases. Data collection will include demographic details, comorbidities, intraoperative variables, and postoperative outcomes. We will use the 5 point Major Adverse Cardiovascular Events (MACE ) criteria to determine postoperative cardiovascular complications.

Statistical Data Analysis

Descriptive Analysis descriptive statistics will be used to summarize the characteristics of the study population, including age, gender, comorbidities, type of cancer surgery, and the incidence of vasopressor/inotrope use. Continuous variables will be described using means and standard deviations, while categorical variables will be described using frequencies and percentages.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All adult patients undergoing elective cancer surgery and requiring intraoperative inotrope or vasopressor drug infusions will be studied.

排除标准

  • Emergency surgeries.

结局指标

主要结局

Number of adult patients undergoing elective cancer surgery requiring intraoperative vasopressor / inotrope infusions

时间窗: At completion of surgery

次要结局

  • 1. To study the indication for starting vasopressor therapy(2. To study the choice of vasoactive agent, the average dose and duration of the agent)

研究者

发起方
Tata memorial Centre Mumbai
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Madhavi Shetmahajan

Tata Memorial Centre, Mumbai

研究点 (1)

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