Clinical trial NCT03103373: Assessment of Plasma Lactate in Non-cardiac Surgery Monitoring by Transthoracic Echocardiography
Official title: Assessment of Plasma Lactate in Patients Underwent Non-cardiac Surgery Monitoring by Transthoracic Echocardiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Keywords: Echocardiography
anesthesia
general surgery
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2017-04-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: plasma lactate
timeFrame: 10 minutes after intubation, before incision
measure: plasma lactate
timeFrame: 10 min after the end of the surgery
Secondary outcomes:
measure: Assessment heart rate
timeFrame: 10 minutes after intubation, before incision
measure: Assessment heart rate
timeFrame: 10 min after the end of the surgery
measure: Assessment blood pressure
timeFrame: 10 minutes after intubation, before incision
measure: Assessment blood pressure
timeFrame: 10 min after the end of the surgery
measure: Assessment venus oximetry
timeFrame: 10 minutes after intubation, before incision
measure: Assessment venus oximetry
timeFrame: 10 min after the end of the surgery
measure: Assessment arterial PH
timeFrame: 10 minutes after intubation, before incision
measure: Assessment arterial PH
timeFrame: 10 min after the end of the surgery
measure: Assessment fluid infusion
timeFrame: 10 min after the end of the surgery
measure: Infection
timeFrame: 30 days after surgery
measure: Surgery complications
timeFrame: 30 days after surgery
measure: Post-operative mortality
timeFrame: 30 days after surgery
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: federal University of Juiz de Fora
state: Minas gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Marcello F Salgado Filho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forget P, Lois F, de Kock M. Goal-directed fluid management based on the pulse oximeter-derived pleth variability index reduces lactate levels and improves fluid management. Anesth Analg. 2010 Oct;111(4):910-4. doi: 10.1213/ANE.0b013e3181eb624f. Epub 2010 Aug 12.
citation: Lobo SM, Rezende E, Knibel MF, Silva NB, Paramo JA, Nacul FE, Mendes CL, Assuncao M, Costa RC, Grion CC, Pinto SF, Mello PM, Maia MO, Duarte PA, Gutierrez F, Silva JM Jr, Lopes MR, Cordeiro JA, Mellot C. Early determinants of death due to multiple organ failure after noncardiac surgery in high-risk patients. Anesth Analg. 2011 Apr;112(4):877-83. doi: 10.1213/ANE.0b013e3181e2bf8e. Epub 2010 Jun 8.
citation: Grocott MP, Dushianthan A, Hamilton MA, Mythen MG, Harrison D, Rowan K; Optimisation Systematic Review Steering Group. Perioperative increase in global blood flow to explicit defined goals and outcomes following surgery. Cochrane Database Syst Rev. 2012 Nov 14;11(11):CD004082. doi: 10.1002/14651858.CD004082.pub5.