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

NCT05142163 | Completed

• 1 other identifier: RGCI/GDFT
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

Goal Directed Fluid Therapy

Keywords

Goal directed Fluid Therapy; Stroke Volume Variation; Plethysmography

Outcome Measures

Primary Outcomes (1)

• 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.

  upto 8 hours

Secondary Outcomes (5)

• To Measure Serum Lactate levels mmol/L in SVV and PVI Group.

  upto 72 hours postoperative

• Postoperative Cardiac complication

  upto72 hours

• Postoperative Respiratory complication

  upto 72 hours

• Postoperative Renal complication

  upto72 hours

• Length of ICU stay

  upto72 hours

Study Arms (2)

Stroke Volume Variation Guided Fluid Therapy

ACTIVE COMPARATOR

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

Plethysmography Variability Index Guided Fluid Therapy

ACTIVE COMPARATOR

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

Interventions

Intraoperative SVV Guided Fluid Therapy OTHER

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.

Stroke Volume Variation Guided Fluid Therapy

Intraoperative PVI Guided Fluid Therapy OTHER

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.

Plethysmography Variability Index Guided Fluid Therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing Open major Oncosurgeries under General Anaesthesia

You may not qualify if:

• Patient Refusal
• Left ventricular Ejection Fraction \<40%
• Cardiac arrythmias
• Severe valvular heart disease
• Peripheral Vascular Disease
• Laparoscopic surgeries

Sponsors & Collaborators

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

Study Sites (1)

Rajiv Gandhi Cancer Institute and Research Centre

Delhi, 110085, India

Location

Study Officials

• Anita Kulkarni, MD

  Senior Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patient were masked about belonging to SVV Guided or PVI Guided Group to receive Intraoperative Fluid Therapy
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Model Details: Patients were allotted to either SVV Guided or PVI Guided Intraoperative Fluid Therapy

Study Record Dates

• First Submitted: November 6, 2021
• First Posted: December 2, 2021
• Study Start: November 8, 2021
• Primary Completion: June 10, 2022
• Study Completion: June 15, 2022
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)