Transesophageal Echocardiology Measured Left Ventricular End Diastolic Area As Guide for Fluid Therapy in Major Oncosurgeries

NCT03853031 | Completed

• 1 other identifier: RGCIRC Rohini
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Intraoperative fluid management is pivotal to successful outcome of major oncosurgeries . Adequate volume replacement to achieve optimal cardiac performance is critical to prevent any deleterious consequences of under resuscitation or fluid overload . Traditionally CVP monitoring has been tool to guide intraoperative fluid therapy and has poor reliability as indicator of volume status . Transesophageal Echocardiography measured LVEDA is more reliable and sensitive measure of left ventricular volume to guide intraoperative fluid therapy . Investigators plan the study comparing total fluid requirement and postoperative outcomes in two groups of patients receiving central venous pressure (CVP) guided Conventional Fluid Therapy (CFT) and Left ventricular end diastolic area( LVEDA) guided fluids for major oncosurgeries.

Conditions

Fluid Therapy DURING SURGERY

Keywords

Fluid therapy; Left ventricular end diastolic area; Central venous pressure

Outcome Measures

Primary Outcomes (1)

• To calculate total intraoperative fluids required in TEE (study) and CVP (control) groups.

  During the surgery Study group will receive fluids ( crystalloids and bolus colloids) guided by LVEDA cm2 and Control group will receive fluids (crystalloids and bolus colloids) guided by CVP cms H20

  Upto 8 hours

Secondary Outcomes (3)

• To compare serum lactate levels in millimols/litre

  upto 48 hours

• To compare serum creatinine in milligrams per decilitre in both the groups

  Upto 48 hours.

• Length of ICU stay

  Upto 10 days

Study Arms (2)

LVEDA guided intraoperative fluid therapy

ACTIVE COMPARATOR

Patients in TEE group will be given crystalloid fluids during surgery guided by LVEDA cm2 to be maintained between 10 -18 cm2 , if LVEDA \< 10 cm2 then 200ml colloid bolus will be given and increase in LVEDA noted.

Procedure: LVEDA cm2 guided intraoperative fluid in TEE /Study Group

CVP guided intraoperative fluid therapy

ACTIVE COMPARATOR

Patients in CVP group will be given crystalloid fluids during surgery guided by CVP values to be maintained between 10 -16 cms of water H2O ,if CVP value \< 10 cms H2O then 200 ml colloid bolus will be given and increase in CVP value noted.

Procedure: CVP guided intraoperative fluid in CVP / Control group

Interventions

LVEDA cm2 guided intraoperative fluid in TEE /Study Group PROCEDURE

Placement of Transoesophageal echocardiography probe in TEE group to measure Left ventricular end diastolic area cm2

LVEDA guided intraoperative fluid therapy

CVP guided intraoperative fluid in CVP / Control group PROCEDURE

Ultrasound guided Internal Jugular Vein catheter placement in CVP group to measure CVP value cms H2O .

CVP guided intraoperative fluid therapy

Eligibility Criteria

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

You may qualify if:

• Patients undergoing major abdominopelvic oncosurgeries .

You may not qualify if:

• oesophageal varices
• carcinoma oesophagus
• carcinoma stomach
• coagulopathies
• duration of surgery exceeding 8 hours.

Sponsors & Collaborators

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

Study Sites (1)

Anita Kulkarni

Delhi, National Capital Territory of Delhi, 110085, India

Location

Related Publications (3)

• Gutierrez MC, Moore PG, Liu H. Goal-directed therapy in intraoperative fluid and hemodynamic management. J Biomed Res. 2013 Sep;27(5):357-65. doi: 10.7555/JBR.27.20120128. Epub 2013 Mar 10.

  PMID: 24086168 BACKGROUND

• Cheung AT, Savino JS, Weiss SJ, Aukburg SJ, Berlin JA. Echocardiographic and hemodynamic indexes of left ventricular preload in patients with normal and abnormal ventricular function. Anesthesiology. 1994 Aug;81(2):376-87. doi: 10.1097/00000542-199408000-00016.

  PMID: 8053588 BACKGROUND

• Marik PE, Cavallazzi R. Does the central venous pressure predict fluid responsiveness? An updated meta-analysis and a plea for some common sense. Crit Care Med. 2013 Jul;41(7):1774-81. doi: 10.1097/CCM.0b013e31828a25fd.

  PMID: 23774337 BACKGROUND

MeSH Terms

Interventions

COP protocol 2; Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Anita Kulkarni, MD

  Rajiv Gandhi Cancer Institute & Research Centre , India

  PRINCIPAL INVESTIGATOR

• Anita Kulkarni, M.D.

  Rajiv Gandhi Cancer Institute & Research Centre , India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will be randomly allotted to either TEE or CVP Group according to computer generated randomization thus will be masked .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: During surgery Control group of patients will receive CVP guided fluids Study group of patients will receive TEE measured LVEDA guided fluids

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 25, 2019
• Study Start: January 6, 2019
• Primary Completion: April 30, 2019
• Study Completion: May 10, 2019
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)