临床试验/NCT03164811

NCT03164811已完成不适用

Goal Directed Fluid Therapy Based on Pulse Pressure Variation Compared With Standard Fluid Therapy in Patients Undergoing Complex Spine Surgery: a Randomized Controlled Trial

Mahidol University2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2017年4月11日最近更新: 2020年2月5日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Mahidol University
入组人数: 60
试验地点: 2
主要终点: episode of intraoperative hypotension

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The investigators will do the Goal directed fluid therapy by protocolized fluid management in the experimental group, using PPV to guide the fluid administration, compare with standard fluid management in patients undergoing complex spine surgery.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 70 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•elective surgery
•thoracic/lumbar spine surgery >= 3 levels and duration >= 3 hours

排除标准

•Cr >2 mg/dl or eGFR < 60 ml/min
•coronary artery disease, congestive heart failure or cardiac arrhythmia
•BMI >30 kg/m2
•hemodynamic unstable, preoperatively
•uncontrolled hypertension
•respiratory system compliance < 30 ml/cmH2O

结局指标

主要结局

episode of intraoperative hypotension

时间窗: intraoperative

Blood pressure will be record continuously using arterial catheter in both group. Number of participants and episode of hypotension (defined as SBP \< 90 mmHg or MAP \< 60 mmHg or decrease of SPB \>= 25% from baseline for 5 minutes or need vasopressor) therapy

次要结局

unit of blood transfusion(intraoperative and up to 24 hours postoperatively)

研究者

发起方

Mahidol University

申办方类型

Other

责任方

Sponsor

研究点 (2)

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