TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery (VTI SVV)

Rajiv Gandhi Cancer Institute & Research Center, India

Status: Completed

Conditions: Fluid Therapy

Treatments: Other: TEE guided fluid therapy will be administered; Other: Stroke volume variation guided intravenous fluid.

Study type: Interventional

Funder types: Other

Identifiers

NCT03140540

RGCI ID:500/AN/ANK-02

Details and patient eligibility

About

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 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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Group A (stroke volume variation) guided fluid

Active Comparator group

Description:

Stroke volume variation guided intraoperative intravenous fluid will be administered.

Treatment:

Other: Stroke volume variation guided intravenous fluid.

Group B(Study group) TEE guided fluid

Active Comparator group

Description:

Transesophageal echocardiography will be used to guide the fluid therapy.

Treatment:

Other: TEE guided fluid therapy will be administered