VTI SVV: TEE as a Guide for Fluid Optimization in Major Abdominal Oncosurgery

• Sponsor: Rajiv Gandhi Cancer Institute & Research Center, India (Other)
• Overall Status: Completed
• CT.gov ID: NCT03140540
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.4
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fluid Therapy	Other: TEE guided fluid therapy will be administered; Other: Stroke volume variation guided intravenous fluid.	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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.
• Masking: Single (Care Provider)
• Masking Description: The intensivist taking care of the patient postoperatively not aware of the intervention
• Primary Purpose: Health Services Research
• Official Title: Transesophageal Echocardiography as a Guide for Fluid Optimization in Major Abdominal Oncosurgery
• Actual Study Start Date: Feb 16, 2019
• Actual Primary Completion Date: Feb 27, 2020
• Actual Study Completion Date: Feb 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A (stroke volume variation) guided fluid Stroke volume variation guided intraoperative intravenous fluid will be administered.	Other: 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
Active Comparator: Group B(Study group) TEE guided fluid Transesophageal echocardiography will be used to guide the fluid therapy.	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.

Outcome Measures

Primary Outcome Measures

1. Postoperative complications [48 hours]

   The incidence of postoperative complications in percentage

Secondary Outcome Measures

1. intraoperative fluid [intraoperative period (hours)]

   Amount of intraoperative fluid in litres to be compared

2. median icu stay [1 week]

   duration of icu stay

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rajiv Gandhi Cancer Institute	Delhi		India	110085

Sponsors and Collaborators

• Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr soumi pathak, Principal Investigator, Rajiv Gandhi Cancer Institute & Research Center, India
• ClinicalTrials.gov Identifier: NCT03140540
• Other Study ID Numbers: RGCI ID:500/AN/ANK-02
• First Posted: May 4, 2017
• Last Update Posted: Oct 26, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr soumi pathak, Principal Investigator, Rajiv Gandhi Cancer Institute & Research Center, India: Fluid management; goal-directed therapy; transesophageal echocardiography

Study Results

No Results Posted as of Oct 26, 2020