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

Not Applicable

• Conditions: Anesthesia

• Registration Number: NCT03103373
• Lead Sponsor: Federal University of Juiz de Fora

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-02-01
• Status Verified: 2017-03
• Study First Submitted: 2017-03-10
• Study First Submitted QC: 2017-03-31
• Last Update Submitted: 2017-03-31
• Study First Posted: 2017-04-06
• Last Update Posted: 2017-04-06
• Primary Completion: 2017-12-01
• Study Completion: 2018-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
plasma lactate	10 min after the end of the surgery	The plasma lactate will be collected in the arterial line

Secondary Outcome Measures

Name	Time	Method
Assessment heart rate	10 min after the end of the surgery	Heart rate
Assessment venus oximetry	10 min after the end of the surgery	venus oximetry
Assessment arterial PH	10 min after the end of the surgery	arterial PH
Post-operative mortality	30 days after surgery	death after surgery
Assessment blood pressure	10 min after the end of the surgery	blood pressure
Assessment fluid infusion	10 min after the end of the surgery	fluid infusion
Surgery complications	30 days after surgery	Assessment fistulae
Infection	30 days after surgery	Assessment sepsis

Trial Locations

Locations (1)

federal University of Juiz de Fora; 🇧🇷 Juiz de Fora, Minas gerais, Brazil