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临床试验/NCT03103373
NCT03103373Unknown不适用

Assessment of Plasma Lactate in Patients Underwent Non-cardiac Surgery Monitoring by Transthoracic Echocardiography

Federal University of Juiz de Fora1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
plasma lactate

研究概览

简要总结

The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).

详细描述

The study is a clinical trial, prospective and randomized of 60 patients of both genders, aged between 18 and 80 years, underwent major abdominal surgery. This study aims to compare plasma lactate levels in patients underwent major abdominal surgery (colectomy, gastrectomy, esophagectomy, pancreatectomy, Wertheim Meigs, liver and spleen surgeries) monitored by echocardiography or by conventional techniques (mean arterial pressure , Central venous pressure).

The investigators expect to observe a decrease in plasma lactate levels in patients submitted to echocardiographic monitoring when compared to patients submitted to conventional monitoring. In this way, to demonstrate that the routine use of transthoracic echocardiography in patients submitted to large surgery improves the clinical outcomes of these patients and presents a lower hospital cost.

The surgical indication will obey the criteria of the Federal University of Juiz de Fora surgery service, after clinical examination and routine preoperative laboratory tests (complete blood count, complete coagulogram, plasma sodium, potassium Plasma urea and plasma creatinine, blood glucose and liver function test), resting electrocardiogram and chest X-ray. All patients who agree to participate in the study will sign an Informed Consent Term in the preanesthetic evaluation (Appendix 1).

Patients will be computer randomly form by the GraphPad Prisma® program into two groups with 30 patients:

Conventional Group, Transthoracic Echocardiogram Group, All survey data will be noted in the Protocol Data Sheet (Appendix 2). Patients will be anesthetized by the researcher Dr. Marcello Fonseca Salgado Filho, who will also be responsible for performing the intraoperative TTE examination.

研究设计

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

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ages between 18 and 80 years.
  • •both genders
  • •Large abdominal surgeries
  • •Elective surgeries

排除标准

  • •Emergency surgeries
  • •Surgeries of the abdominal aorta
  • •Ejection fraction <30%
  • •Blood creatinine levels> 2.0mg / dl
  • •Glycemia> 200 g / dl
  • •Do not agree to participate in the study
  • •Bowel obstruction
  • •Bilirubin> 300 g / dl
  • •Alcoholism

研究组 & 干预措施

Conventional monitor group

Active Comparator

Patients will be monitoring with invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography Echocardiography group: Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnogrphy and electrocardiography

干预措施: Conventional monitor (Device)

Echocardiography group

Active Comparator

Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography

干预措施: Echocardiography (Device)

结局指标

主要结局

plasma lactate

时间窗: 10 min after the end of the surgery

The plasma lactate will be collected in the arterial line

plasma lactate

时间窗: 10 minutes after intubation, before incision

The plasma lactate will be collected in the arterial line

次要结局

  • Assessment heart rate(10 min after the end of the surgery)
  • Assessment venus oximetry(10 min after the end of the surgery)
  • Assessment arterial PH(10 min after the end of the surgery)
  • Post-operative mortality(30 days after surgery)
  • Assessment blood pressure(10 min after the end of the surgery)
  • Assessment fluid infusion(10 min after the end of the surgery)
  • Surgery complications(30 days after surgery)
  • Infection(30 days after surgery)
  • Assessment heart rate(10 minutes after intubation, before incision)
  • Assessment blood pressure(10 minutes after intubation, before incision)
  • Assessment venus oximetry(10 minutes after intubation, before incision)
  • Assessment arterial PH(10 minutes after intubation, before incision)

研究者

发起方
Federal University of Juiz de Fora
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcello F Salgado Filho, MD

Professor of Anesthesiology

Federal University of Juiz de Fora

研究点 (1)

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