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

March 3, 2024 updated by: Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India
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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
68

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
      • Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute And Research Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Stroke Volume Variation Guided Fluid Therapy
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.
Other: Intraoperative SVV Guided Fluid Therapy
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.
Active Comparator: Plethysmography Variability Index Guided Fluid Therapy
Patients will receive maintenance Fluids as crystalloids intraoperative to maintain PVI <11%, for values >11%colloid bolus 6%hydroxyethyl starch will be given and fluid responsiveness noted.
Other: Intraoperative PVI Guided Fluid Therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To compare Total intraoperative Fluid requirement in millilitres and Fluid Responsiveness in SVV and PVI Group.
Time Frame: upto 8 hours
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.
upto 8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
To Measure Serum Lactate levels mmol/L in SVV and PVI Group.
Time Frame: upto 72 hours postoperative

Intraoperative at beginning and end of surgery and upto 72 hours serum Lactate levels will

be measured.
upto 72 hours postoperative
Postoperative Cardiac complication
Time Frame: upto72 hours
Requirement of Inotrope Nonadrenaline
upto72 hours
Postoperative Respiratory complication
Time Frame: upto 72 hours
Ventilator support
upto 72 hours
Postoperative Renal complication
Time Frame: upto72 hours
Increase serum creatinine values
upto72 hours
Length of ICU stay
Time Frame: upto72 hours
Duration in hours stay in PACU
upto72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anita Kulkarni, MD, Senior consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 8, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 10, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RGCI/GDFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings