Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Oncosurgeries

NCT06026475 | Completed

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

Brief Summary

Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery and reducing postoperative morbidity after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery .The key elements of ERAS protocols include preoperative counselling, optimization of nutrition, standardized analgesic and anesthetic regimens , goal directed fluid therapy early mobilization.

Conditions

Fluid Loss; Enhanced Recovery

Keywords

Goal Directed Fluid Therapy; Stroke volume variation; Enhanced recovery after surgery

Outcome Measures

Primary Outcomes (2)

• Duration of ICU stay

  Time of shifting of patients in both group to the ward in hours.

  upto 5 days .

• Postoperative serum Lactate levels mmol/L

  Serum lactate levels will be measured in the SICU

  upto 48 hours

Secondary Outcomes (1)

• Serum Creatinine levels mg/dL.

  Upto 48 hours.

Study Arms (2)

Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)

ACTIVE COMPARATOR

When SVV values will increase above 11 colloid bolus 200ml will be administered. postbolus change in values of SVV , SV , SVI and CI shall be noted.

Procedure: Goal directed Fluid Therapy

Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .

ACTIVE COMPARATOR

When CVP values will decrease below 8 cmsH20 colloid bolus 200ml will be administered .Postbolus change in values shall be noted .

Procedure: Conventional Fluid Therapy

Interventions

Goal directed Fluid Therapy PROCEDURE

Patients will receive fluid during surgery with goal of maintaining SVV below 11

Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)

Conventional Fluid Therapy PROCEDURE

Patients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20

Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective major open gastrointestinal Oncosurgeries .

You may not qualify if:

• Patient refusal.
• Robotic surgery.
• Laparoscopic surgery.
• Arrythmias.

Sponsors & Collaborators

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

Study Sites (1)

Anita Kulkarni

New Delhi, Please Select, 110078, India

Location

Related Publications (1)

• Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.

  PMID: 29369117 BACKGROUND

Study Officials

• Anita Kulkarni, MD

  Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participant will be masked about allotment of interventional group either CVP or SVV .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients in Conventional Group will be given intraoperative fluids guided by CVP Values . Patients in GDFT Group will be given fluids guided by SVV values.

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: September 7, 2023
• Study Start: July 13, 2023
• Primary Completion: January 19, 2024
• Study Completion: January 30, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)