TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

Fluid Therapy Clinical Trial

— VTI SVV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140540
• Other study ID #: RGCI ID:500/AN/ANK-02
• Status: Completed
• Phase: N/A
• Start date: February 16, 2019
• Est. completion date: February 27, 2020

Study information

• Verified date: October 2020
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 27, 2020
• Est. primary completion date: February 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fluid Therapy

Intervention

Other:
• TEE 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.
• Stroke 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

Locations

Country	Name	City	State
India	Rajiv Gandhi Cancer Institute	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

References & Publications (2)

Guarracino F. [The role of transesophageal echocardiography in intraoperative hemodynamic monitoring]. Minerva Anestesiol. 2001 Apr;67(4):320-4. Italian. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative complications	The incidence of postoperative complications in percentage	48 hours
Secondary	intraoperative fluid	Amount of intraoperative fluid in litres to be compared	intraoperative period (hours)
Secondary	median icu stay	duration of icu stay	1 week