TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

NCT03140540 | Completed DMC

• 1 other identifier: RGCI ID:500/AN/ANK-02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Fluid Therapy

Keywords

Fluid management; goal-directed therapy; transesophageal echocardiography

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  The incidence of postoperative complications in percentage

  48 hours

Secondary Outcomes (2)

• intraoperative fluid

  intraoperative period (hours)

• median icu stay

  1 week

Study Arms (2)

Group A (stroke volume variation) guided fluid

ACTIVE COMPARATOR

Stroke volume variation guided intraoperative intravenous fluid will be administered.

Other: Stroke volume variation guided intravenous fluid.

Group B(Study group) TEE guided fluid

ACTIVE COMPARATOR

Transesophageal echocardiography will be used to guide the fluid therapy.

Other: TEE guided fluid therapy will be administered

Interventions

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.

Group B(Study group) TEE guided fluid

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

Group A (stroke volume variation) guided fluid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA 1, 2 and 3
• Undergoing major abdominal oncosurgery

You may not qualify if:

• Any contraindication for TEE probe insertion as oesophageal varices , oesophageal and gastric carcinoma , severe left ventricular hypertrophy , coagulopathy.

Sponsors & Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India: lead

Study Sites (1)

Rajiv Gandhi Cancer Institute

Delhi, 110085, India

Location

Related Publications (2)

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

  PMID: 11376533 RESULT

• 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.

  PMID: 24354071 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The intensivist taking care of the patient postoperatively not aware of the intervention
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 15, 2017
• First Posted: May 4, 2017
• Study Start: February 16, 2019
• Primary Completion: February 27, 2020
• Study Completion: February 27, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)