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

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ClinicalTrials.gov Identifier: NCT03103373
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : April 6, 2017
Sponsor:
Information provided by (Responsible Party):
Marcello F Salgado Filho, MD, 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).

Condition or disease Intervention/treatment Phase
Anesthesia Device: Conventional monitor Device: Echocardiography Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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

Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Plasma Lactate in Patients Underwent Non-cardiac Surgery Monitoring by Transthoracic Echocardiography
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 1, 2017
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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




Primary Outcome Measures :
  1. plasma lactate [ Time Frame: 10 minutes after intubation, before incision ]
    The plasma lactate will be collected in the arterial line

  2. plasma lactate [ Time Frame: 10 min after the end of the surgery ]
    The plasma lactate will be collected in the arterial line


Secondary Outcome Measures :
  1. Assessment heart rate [ Time Frame: 10 minutes after intubation, before incision ]
    Heart rate

  2. Assessment heart rate [ Time Frame: 10 min after the end of the surgery ]
    Heart rate

  3. Assessment blood pressure [ Time Frame: 10 minutes after intubation, before incision ]
    blood pressure

  4. Assessment blood pressure [ Time Frame: 10 min after the end of the surgery ]
    blood pressure

  5. Assessment venus oximetry [ Time Frame: 10 minutes after intubation, before incision ]
    venus oximetry

  6. Assessment venus oximetry [ Time Frame: 10 min after the end of the surgery ]
    venus oximetry

  7. Assessment arterial PH [ Time Frame: 10 minutes after intubation, before incision ]
    arterial PH

  8. Assessment arterial PH [ Time Frame: 10 min after the end of the surgery ]
    arterial PH

  9. Assessment fluid infusion [ Time Frame: 10 min after the end of the surgery ]
    fluid infusion

  10. Infection [ Time Frame: 30 days after surgery ]
    Assessment sepsis

  11. Surgery complications [ Time Frame: 30 days after surgery ]
    Assessment fistulae

  12. Post-operative mortality [ Time Frame: 30 days after surgery ]
    death after surgery



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103373


Contacts
Contact: Marcello F Salgado Filho, PhD +5532999858833 mfonsecasalgado@hotmail.com
Contact: Izabela P Silva, MsC +5532991152615 izabelapalitot@hotmail.com

Locations
Brazil
federal University of Juiz de Fora Recruiting
Juiz de Fora, Minas gerais, Brazil, 36036-900
Contact: Marcello F Salgado Filho, PhD    +5532999858833    mfonsecasalgado@hotmail.com   
Principal Investigator: Marcello F. Salgado Filho, PhD         
Sponsors and Collaborators
Federal University of Juiz de Fora
Investigators
Principal Investigator: Marcello F Salgado Filho, PhD Federal University of Juiz de Fora

Additional Information:
Publications of Results:
Responsible Party: Marcello F Salgado Filho, MD, Professor of Anesthesiology, Federal University of Juiz de Fora
ClinicalTrials.gov Identifier: NCT03103373     History of Changes
Other Study ID Numbers: CAAE: 60721816.9.0000.5139
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: April 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Marcello F Salgado Filho, MD, Federal University of Juiz de Fora:
Echocardiography
anesthesia
general surgery