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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03103373
• Other study ID #: CAAE: 60721816.9.0000.5139
• Status: Recruiting
• Phase: N/A
• First received: March 10, 2017
• Last updated: March 31, 2017
• Start date: February 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: March 2017
• Source: Federal University of Juiz de Fora
• Contact: Marcello F Salgado Filho, PhD
• Phone: +5532999858833
• Email: mfonsecasalgado[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2018
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Device:
• Conventional monitor
Patients underwent non-cardiac surgery will be monitoring by regular monitors
• Echocardiography
Patients will be monitoring by regular monitors plus echocardiography

Locations

Country	Name	City	State
Brazil	federal University of Juiz de Fora	Juiz de Fora	Minas gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

References & 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 — View 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 — View Citation

Lobo SM, Rezende E, Knibel MF, Silva NB, Páramo JA, Nácul FE, Mendes CL, Assunção 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 f — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma lactate	The plasma lactate will be collected in the arterial line	10 minutes after intubation, before incision
Primary	plasma lactate	The plasma lactate will be collected in the arterial line	10 min after the end of the surgery
Secondary	Assessment heart rate	Heart rate	10 minutes after intubation, before incision
Secondary	Assessment heart rate	Heart rate	10 min after the end of the surgery
Secondary	Assessment blood pressure	blood pressure	10 minutes after intubation, before incision
Secondary	Assessment blood pressure	blood pressure	10 min after the end of the surgery
Secondary	Assessment venus oximetry	venus oximetry	10 minutes after intubation, before incision
Secondary	Assessment venus oximetry	venus oximetry	10 min after the end of the surgery
Secondary	Assessment arterial PH	arterial PH	10 minutes after intubation, before incision
Secondary	Assessment arterial PH	arterial PH	10 min after the end of the surgery
Secondary	Assessment fluid infusion	fluid infusion	10 min after the end of the surgery
Secondary	Infection	Assessment sepsis	30 days after surgery
Secondary	Surgery complications	Assessment fistulae	30 days after surgery
Secondary	Post-operative mortality	death after surgery	30 days after surgery

External Links

•   anesthesia and analgesia
•   cochrane