TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

Overview

Transesophageal echocardiography (TEE) as guide for tailoring perioperative fluid therapy to achieve individualized hemodynamic endpoint, target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery. Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis intraoperatively, after 12 hours and 48 hrs postoperatively

Full Title of Study: “Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: February 27, 2020

Detailed Description

TEE as guide for tailoring perioperative fluid therapy to achieve target hemodynamic goals of stroke volume index (SVI) greater than 35 mL/m2 and cardiac index greater than 2.5 L/min/m2 and tissue oxygen delivery. GDT (goal directed therapy): continuous infusion of crystalloids 2 mL/kg/h. If (velocity time integral) VTI <20, 250 mL colloid bolus administered. Dose repeated every 10 min until goal of VTI >20 met. Norepinephrine titrated to maintain MAP(mean arterial pressure) > 65 mm Hg. Blood transfused for haemoglobin <8 g Lactate levels as a surrogate indicator of organ perfusion as measured by arterial blood gas analysis at time of incision intraoperatively and after 12 hours and 48 hrs. The incidence of postoperative complications, morbidity, mortality, duration of mechanical ventilation and ICU stay.

Interventions

  • Other: TEE guided fluid therapy will be administered
    • Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered.
  • Other: Stroke volume variation guided intravenous fluid.
    • Active Comparator: Group A control group (SVV guided fluid ) Stroke volume variation guided intraoperative intravenous fluid will be administered. SVV >10, 200 ml of colloid bolus to be given

Arms, Groups and Cohorts

  • Active Comparator: Group A (stroke volume variation) guided fluid
    • Stroke volume variation guided intraoperative intravenous fluid will be administered.
  • Active Comparator: Group B(Study group) TEE guided fluid
    • Transesophageal echocardiography will be used to guide the fluid therapy.

Clinical Trial Outcome Measures

Primary Measures

  • Postoperative complications
    • Time Frame: 48 hours
    • The incidence of postoperative complications in percentage

Secondary Measures

  • intraoperative fluid
    • Time Frame: intraoperative period (hours)
    • Amount of intraoperative fluid in litres to be compared
  • median icu stay
    • Time Frame: 1 week
    • duration of icu stay

Participating in This Clinical Trial

Inclusion Criteria

  • ASA 1, 2 and 3 – Undergoing major abdominal oncosurgery Exclusion Criteria:

  • Any contraindication for TEE probe insertion as oesophageal varices , oesophageal and gastric carcinoma , severe left ventricular hypertrophy , coagulopathy.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Rajiv Gandhi Cancer Institute & Research Center, India
  • Provider of Information About this Clinical Study
    • Principal Investigator: Dr soumi pathak, Principal Investigator – Rajiv Gandhi Cancer Institute & Research Center, India

Citations Reporting on Results

Guarracino F. [The role of transesophageal echocardiography in intraoperative hemodynamic monitoring]. Minerva Anestesiol. 2001 Apr;67(4):320-4. Italian.

Trinooson CD, Gold ME. Impact of goal-directed perioperative fluid management in high-risk surgical procedures: a literature review. AANA J. 2013 Oct;81(5):357-68.

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