TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03140540

Acronym

VTI SVV

Enrollment

Registered

2017-05-04

Start date

2019-02-16

Completion date

2020-02-27

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Therapy

Keywords

Fluid management, goal-directed therapy, transesophageal echocardiography

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.

Interventions

OTHERTEE 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.

OTHERStroke 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE (Caregiver)

Masking description

The intensivist taking care of the patient postoperatively not aware of the intervention

Intervention 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.

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Postoperative complications	48 hours	The incidence of postoperative complications in percentage

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026