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Completed

NCT Number: NCT03140540

TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

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

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Key information

Conditions

Fluid Therapy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rajiv Gandhi Cancer Institute

Delhi, 110085, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEE guided fluid therapy will be administered

Other

Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered.

Stroke volume variation guided intravenous fluid.

Other

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

Primary outcomes

  1. Postoperative complications

    Time frame: 48 hours

    The incidence of postoperative complications in percentage

Secondary outcomes

  1. intraoperative fluid

    Time frame: intraoperative period (hours)

    Amount of intraoperative fluid in litres to be compared

  2. median icu stay

    Time frame: 1 week

    duration of icu stay

Sponsors and collaborators

Lead sponsor

Rajiv Gandhi Cancer Institute & Research Center, India

Other

Registry information

Official study title

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

Acronym: VTI SVV

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 4, 2017
Registry last updated
Oct 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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