Clinical trial NCT03140540: TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
Official title: Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fluid Therapy
Keywords: Fluid management
goal-directed therapy
transesophageal echocardiography
Lead sponsor: Rajiv Gandhi Cancer Institute & Research Center, India
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Postoperative complications
timeFrame: 48 hours
Secondary outcomes:
measure: intraoperative fluid
timeFrame: intraoperative period (hours)
measure: median icu stay
timeFrame: 1 week
Other outcomes:
Locations:
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute
Study officials:
References:
citation: Guarracino F. [The role of transesophageal echocardiography in intraoperative hemodynamic monitoring]. Minerva Anestesiol. 2001 Apr;67(4):320-4. Italian.
citation: Trinooson CD, Gold ME. Impact of goal-directed perioperative fluid management in high-risk surgical procedures: a literature review. AANA J. 2013 Oct;81(5):357-68.