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

NCT03103373 | Unknown DMC FDA Device

• 1 other identifier: CAAE: 60721816.9.0000.5139
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Anesthesia

Keywords

Echocardiography; anesthesia; general surgery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Assessment heart rate

  10 minutes after intubation, before incision

• Assessment heart rate

  10 min after the end of the surgery

• Assessment blood pressure

  10 minutes after intubation, before incision

• Assessment blood pressure

  10 min after the end of the surgery

• Assessment venus oximetry

  10 minutes after intubation, before incision

Study Arms (2)

Conventional monitor group

ACTIVE COMPARATOR

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

Echocardiography group

ACTIVE COMPARATOR

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

Device: Echocardiography

Interventions

Conventional monitor DEVICE

Patients underwent non-cardiac surgery will be monitoring by regular monitors

Conventional monitor group

Echocardiography DEVICE

Patients will be monitoring by regular monitors plus echocardiography

Echocardiography group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages between 18 and 80 years.
• both genders
• Large abdominal surgeries
• Elective surgeries

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36036-900, Brazil

RECRUITING

Related Publications (3)

• 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.

  PMID: 20705785 RESULT

• 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.

  PMID: 20530615 RESULT

• 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.

  PMID: 23152223 RESULT

Related Links

• anesthesia and analgesia
• cochrane

MeSH Terms

Interventions

Echocardiography

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Officials

• Marcello F Salgado Filho, PhD

  Federal University of Juiz de Fora

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcello F Salgado Filho, PhD

CONTACT

+5532999858833; mfonsecasalgado@hotmail.com

Izabela P Silva, MsC

CONTACT

+5532991152615; izabelapalitot@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: 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

Study Record Dates

• First Submitted: March 10, 2017
• First Posted: April 6, 2017
• Study Start: February 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 6, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)