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Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries (SVV PVI GDFT)

Primary Purpose

Goal Directed Fluid Therapy

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Intraoperative SVV Guided Fluid Therapy
Intraoperative PVI Guided Fluid Therapy
Sponsored by
Rajiv Gandhi Cancer Institute & Research Center, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Goal Directed Fluid Therapy focused on measuring Goal directed Fluid Therapy, Stroke Volume Variation, Plethysmography

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients undergoing Open major Oncosurgeries under General Anaesthesia

Exclusion Criteria

Patient Refusal

Left ventricular Ejection Fraction <40%

Cardiac arrythmias

Severe valvular heart disease

Peripheral Vascular Disease

Laparoscopic surgeries

Sites / Locations

  • Rajiv Gandhi Cancer Institute and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Stroke Volume Variation Guided Fluid Therapy

Plethysmography Variability Index Guided Fluid Therapy

Arm Description

Patients will receive maintenance Fluids as crystalloids intraoperative to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.

Patients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.

Outcomes

Primary Outcome Measures

To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.
Patients in SVV Group will receive Crystalloids and colloid bolus 200ml to maintain SVV <11 .Patients in PVI Group will receive Crystalloids and colloid bolus to maintain PVI<11, Postbolus response to SVV and PVI values will be noted.

Secondary Outcome Measures

To Measure Serum Lactate levels mmol/L in SVV and PVI Group.
Intraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will be measured.
Postoperative Cardiac complication
Requirement of Inotrope Nonadrenaline
Postoperative Respiratory complication
Ventilator support
Postoperative Renal complication
Increase serum creatinine values
Length of ICU stay
Duration in hours stay in PACU

Full Information

First Posted
November 6, 2021
Last Updated
July 8, 2022
Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India
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1. Study Identification

Unique Protocol Identification Number
NCT05142163
Brief Title
Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries
Acronym
SVV PVI GDFT
Official Title
Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rajiv Gandhi Cancer Institute & Research Center, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients were allotted to two Groups , SVV Guided Fluid Therapy Group received intraoperative fluids to maintain SVV <11 , and PVI Guided Group received intraoperative Fluids to maintain PVI<11
Detailed Description
Preinduction Epidural catheter will be placed and Standard General Anaesthesia with Volume Controlled Ventilation (Tidal Volume 8ml/Kilogram ) and Positive End Expiratory Pressure 5 centimeters of water for all patients. Postinduction Radial artery cannulation and Ultrasound guided Internal Jugular cannulation will be performed for all patients .Maintenance Fluid crystalloids 2ml/kg will be given to both the Groups. In Stroke Volume Variation SVV Group Flotrac Transducer (MHD8 model Edwards Lifesciences LLC, Irvine,CA 92614,USA) will be attached to radial artery cannula to obtain SVV values and for values < 11 colloid bolus 200ml will be given over 10 minutes and postbolus values noted. In Plethysmography Variability Index PVI Group pulse Oximeter will be placed on index finger and covered to avoid ambient light will be attached to Masimo Radical 97 Monitor to measure continuous Perfusion Index and Plethysmography Variability Index for values <11 colloid bolus 200ml will be given over 10 minutes and change in PVI value noted. Intraoperative heart rate , Mean arterial Pressure , Oxygen Saturation, End tidal carbon dioxide, Central venous pressure , Urine output will be measured in all patients.With optimal fluids if Mean Arterial Pressure is below 70 mmHg than titrating dosage Norepinephrine infusion will be commenced.At the end of surgery reversal agents will be administered and trachea extubated , note will be made of any patient requiring postoperative ventilator support.Arterial blood gas analysis will be performed at beginning and end of surgery and at postoperative 24 and 48 hours to measure serum lactate levels . Patient will be monitored in Postanaesthesia Care Unit for any Cardiac , Respiratory event , Serum Creatinine levels will be measures at 24 and 48 hours , Appearance of bowel sounds will be noted , Length of ICU stay will be recorded for all patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Goal Directed Fluid Therapy
Keywords
Goal directed Fluid Therapy, Stroke Volume Variation, Plethysmography

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients were allotted to either SVV Guided or PVI Guided Intraoperative Fluid Therapy
Masking
Participant
Masking Description
Patient were masked about belonging to SVV Guided or PVI Guided Group to receive Intraoperative Fluid Therapy
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke Volume Variation Guided Fluid Therapy
Arm Type
Active Comparator
Arm Description
Patients will receive maintenance Fluids as crystalloids intraoperative to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Arm Title
Plethysmography Variability Index Guided Fluid Therapy
Arm Type
Active Comparator
Arm Description
Patients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Intervention Type
Other
Intervention Name(s)
Intraoperative SVV Guided Fluid Therapy
Intervention Description
Patients will receive intraoperative maintenance Fluids as crystalloids to maintain SVV <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Intervention Type
Other
Intervention Name(s)
Intraoperative PVI Guided Fluid Therapy
Intervention Description
Patients will receive intraoperative maintenance Fluids as crystalloids to maintain PVI <10%, for values >10%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Primary Outcome Measure Information:
Title
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.
Description
Patients in SVV Group will receive Crystalloids and colloid bolus 200ml to maintain SVV <11 .Patients in PVI Group will receive Crystalloids and colloid bolus to maintain PVI<11, Postbolus response to SVV and PVI values will be noted.
Time Frame
upto 8 hours
Secondary Outcome Measure Information:
Title
To Measure Serum Lactate levels mmol/L in SVV and PVI Group.
Description
Intraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will be measured.
Time Frame
upto 72 hours postoperative
Title
Postoperative Cardiac complication
Description
Requirement of Inotrope Nonadrenaline
Time Frame
upto72 hours
Title
Postoperative Respiratory complication
Description
Ventilator support
Time Frame
upto 72 hours
Title
Postoperative Renal complication
Description
Increase serum creatinine values
Time Frame
upto72 hours
Title
Length of ICU stay
Description
Duration in hours stay in PACU
Time Frame
upto72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients undergoing Open major Oncosurgeries under General Anaesthesia Exclusion Criteria Patient Refusal Left ventricular Ejection Fraction <40% Cardiac arrythmias Severe valvular heart disease Peripheral Vascular Disease Laparoscopic surgeries
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Kulkarni, MD
Organizational Affiliation
Senior Consultant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre
City
Delhi
ZIP/Postal Code
110085
Country
India

12. IPD Sharing Statement

Plan to Share IPD
No

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Stroke Volume Variation and Plethysmography Variability Index as Goal Directed Fluid Therapy in Major Oncosurgeries

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