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Clinical Trials/NCT03140540
NCT03140540
Completed
Not Applicable

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

Rajiv Gandhi Cancer Institute & Research Center, India1 site in 1 country60 target enrollmentFebruary 16, 2019
ConditionsFluid Therapy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Fluid Therapy
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Enrollment
60
Locations
1
Primary Endpoint
Postoperative complications
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 16, 2019
End Date
February 27, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
Responsible Party
Principal Investigator
Principal Investigator

Dr soumi pathak

Principal Investigator

Rajiv Gandhi Cancer Institute & Research Center, India

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Postoperative complications

Time Frame: 48 hours

The incidence of postoperative complications in percentage

Secondary Outcomes

  • intraoperative fluid(intraoperative period (hours))
  • median icu stay(1 week)

Study Sites (1)

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