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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2018-01-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study is a clinical trial, prospective and random type, in which 60 patients, of both genders, aged between 18 and 80 years, who will undergo major abdominal surgery, divided in two groups.

Patients will be randomly divided into two groups with 35 patients:

Conventional Group, Transthoracic Echocardiogram Group

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Conventional monitor group

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

Group Type ACTIVE_COMPARATOR

Conventional monitor

Intervention Type DEVICE

Patients underwent non-cardiac surgery will be monitoring by regular monitors

Echocardiography group

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

Group Type ACTIVE_COMPARATOR

Echocardiography

Intervention Type DEVICE

Patients will be monitoring by regular monitors plus echocardiography

Interventions

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Conventional monitor

Patients underwent non-cardiac surgery will be monitoring by regular monitors

Intervention Type DEVICE

Echocardiography

Patients will be monitoring by regular monitors plus echocardiography

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

ages between 18 and 80 years.

* both genders
* Large abdominal surgeries
* Elective surgeries

Exclusion Criteria

* 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
* Sepsis
* Bilirubin\> 300 g / dl
* Alcoholism

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No