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

Federal University of Juiz de Fora

Status: Unknown

Conditions: Anesthesia

Treatments: Device: Conventional monitor; Device: Echocardiography

Study type: Interventional

Funder types: Other

Identifiers

NCT03103373

CAAE: 60721816.9.0000.5139

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Conventional monitor group

Active Comparator group

Description:

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

Treatment:

Device: Conventional monitor

Echocardiography group

Active Comparator group

Description:

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

Treatment:

Device: Echocardiography