TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

Not Applicable

Completed

• Conditions: Fluid Therapy
• Interventions: Other: TEE guided fluid therapy will be administered; Other: Stroke volume variation guided intravenous fluid.

• Registration Number: NCT03140540
• Lead Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-04-15
• Study First Submitted QC: 2017-05-03
• Study First Posted: 2017-05-04
• Study Start: 2019-02-16
• Primary Completion: 2020-02-27
• Study Completion: 2020-02-27
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Postoperative complications	48 hours	The incidence of postoperative complications in percentage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Rajiv Gandhi Cancer Institute; 🇮🇳 Delhi, India