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

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

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).

Study Overview

• Status: Unknown
• Conditions: Anesthesia
• Intervention / Treatment: Device: Conventional monitor; Device: Echocardiography

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marcello F Salgado Filho, PhD; Phone Number: +5532999858833; Email: mfonsecasalgado@hotmail.com
• Study Contact Backup: Name: Izabela P Silva, MsC; Phone Number: +5532991152615; Email: izabelapalitot@hotmail.com

Study Locations

• Brazil
  • Minas gerais
    • Juiz de Fora, Minas gerais, Brazil, 36036-900
      • Recruiting
      • Federal University of Juiz de Fora
      • Contact: Marcello F Salgado Filho, PhD; Phone Number: +5532999858833; Email: mfonsecasalgado@hotmail.com
      • Principal Investigator: Marcello F. Salgado Filho, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Federal University of Juiz de Fora
• Investigators: Principal Investigator: Marcello F Salgado Filho, PhD, Federal University of Juiz de Fora

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Helpful Links

• anesthesia and analgesia
• cochrane

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2017
• Study Completion (ANTICIPATED): January 1, 2018

Study Registration Dates

• First Submitted: March 10, 2017
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2017
• Last Update Submitted That Met QC Criteria: March 31, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: anesthesia; Echocardiography; general surgery
• Other Study ID Numbers: CAAE: 60721816.9.0000.5139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No