TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

Conditions
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Fluid Therapy

Intervention / Treatment
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* Other: TEE guided fluid therapy will be administered
* Other: Stroke volume variation guided intravenous fluid.


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A (stroke volume variation) guided fluid<br>Stroke volume variation guided intraoperative intravenous fluid will be administered. | Other: Stroke volume variation guided intravenous fluid.<br>* 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<br>|
| Active Comparator: Group B(Study group) TEE guided fluid<br>Transesophageal echocardiography will be used to guide the fluid therapy. | Other: TEE guided fluid therapy will be administered<br>* Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | The incidence of postoperative complications in percentage | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraoperative fluid | Amount of intraoperative fluid in litres to be compared | intraoperative period (hours) | 
| median icu stay | duration of icu stay | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fluid management, goal-directed therapy, transesophageal echocardiography