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

Study Overview
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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).

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.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Conventional monitor
* Device: Echocardiography


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional monitor group<br>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 | Device: Conventional monitor<br>* Patients underwent non-cardiac surgery will be monitoring by regular monitors<br>|
| Active Comparator: Echocardiography group<br>Patients will be monitoring with echocardiography, invasive blood pressure, central venus catheter, plasma lactate, urinary output, oximeter, capnography and electrocardiography | Device: Echocardiography<br>* Patients will be monitoring by regular monitors plus echocardiography<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lactate | The plasma lactate will be collected in the arterial line | 10 minutes after intubation, before incision | 
| plasma lactate | The plasma lactate will be collected in the arterial line | 10 min after the end of the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment heart rate | Heart rate | 10 minutes after intubation, before incision | 
| Assessment heart rate | Heart rate | 10 min after the end of the surgery | 
| Assessment blood pressure | blood pressure | 10 minutes after intubation, before incision | 
| Assessment blood pressure | blood pressure | 10 min after the end of the surgery | 
| Assessment venus oximetry | venus oximetry | 10 minutes after intubation, before incision | 
| Assessment venus oximetry | venus oximetry | 10 min after the end of the surgery | 
| Assessment arterial PH | arterial PH | 10 minutes after intubation, before incision | 
| Assessment arterial PH | arterial PH | 10 min after the end of the surgery | 
| Assessment fluid infusion | fluid infusion | 10 min after the end of the surgery | 
| Infection | Assessment sepsis | 30 days after surgery | 
| Surgery complications | Assessment fistulae | 30 days after surgery | 
| Post-operative mortality | death after surgery | 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Echocardiography, anesthesia, general surgery