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Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Oncosurgeries (GDFT ERAS)

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ClinicalTrials.gov Identifier: NCT06026475
Recruitment Status : Completed
First Posted : September 7, 2023
Last Update Posted : March 5, 2024
Sponsor:
Information provided by (Responsible Party):
Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fluid Loss Enhanced Recovery Procedure: Goal directed Fluid Therapy Procedure: Conventional Fluid Therapy Not Applicable

Detailed Description:

For the proposed study investigators plan to include total 60 patients with 30 each allotted to GDFT(SVV) and CVP Group ,belonging to ASA ( American Society of Anesthesiology)Grade I/II/III, study will be conducted after obtaining written informed consent from all patients and approval from the scientific committee and Institutional Review Board (IRB). All patients will receive one-third starvation fluid as crystalloid during first hour of surgery . Night prior to and on the day of surgery carbo load will be given to all patients according to the protocol.Monitoring included 5 lead ECG SPO2,ETCO2, Invasive Blood Pressure (IBP - Radial),CVP(site IJV),core Temperature .

Standard General anaesthesia with oral Endotracheal tube and Intermittent Positive Pressure Ventilation will be given to all patients.Patients will be allotted randomly to either Goal Directed Fluid Therapy (GDFT) /SVV - Stroke Volume Variation or Conventional Central Venous Pressure - CVP guided fluid Therapy Group.

During the surgery - Heart rate , Mean arterial Blood Pressure , Urine output , Blood loss , Seum lactate levels will be noted.

For SVV Group - SVV , Stroke Volume Index (SVI) , Systemic vascular resistance index (SVRI) ,Cardiac Index (CI) values will be noted every 30 minutes- the goal is to maintain SVV value >11 and to give colloid bolus 200ml whenever SVV values rise above11.Pre and post bolus SVV, SV, SVI and SVRI shall be recorded.

For CVP Group - Goal is to maintain CVP values between 8-12 cmsH20 and for decrease in value < 8 colloid bolus of 200ml will be given and change in CVP value will be noted.

Patients in both the groups will receive Noradrenaline infusion if MAP <70 mmHg with optimal fluid transfusion .Target for transfusing Packed red blood cells will be value of haematocrit < 24 Postoperative HR, MAP, I/O-charting, Serum Creatinine, Serum Lactate, bowel sounds, Inotrope requirement, Visual Analogue Score, Ryles Tube Feeds, Epidural analgesia ,Length of stay (hours in SICU) and any postoperative complications shall be noted.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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.
Masking: Single (Participant)
Masking Description: Participant will be masked about allotment of interventional group either CVP or SVV .
Primary Purpose: Treatment
Official Title: Role of Goal Directed Fluid Therapy in Enhanced Recovery After Surgery in Gastro-intestinal Onco-surgeries
Actual Study Start Date : July 13, 2023
Actual Primary Completion Date : January 19, 2024
Actual Study Completion Date : January 30, 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Intraoperative Goal Directed Fluid Therapy (GDFT) guided by Stroke Volume Variation (SVV)
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
Patients will receive fluid during surgery with goal of maintaining SVV below 11
Active Comparator: Intraoperative Conventional Fluid Therapy (CFT) guided by Central Venous Pressure (CVP) .
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
Patients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20


Outcome Measures
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Primary Outcome Measures :
  1. Duration of ICU stay [ Time Frame: upto 5 days . ]
    Time of shifting of patients in both group to the ward in hours.

  2. Postoperative serum Lactate levels mmol/L [ Time Frame: upto 48 hours ]
    Serum lactate levels will be measured in the SICU


Secondary Outcome Measures :
  1. Serum Creatinine levels mg/dL. [ Time Frame: Upto 48 hours. ]
    Serum Creatinine levels will be measured in the SICU .


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Elective major open gastrointestinal Oncosurgeries .

Exclusion Criteria:

  • Patient refusal.
  • Robotic surgery.
  • Laparoscopic surgery.
  • Arrythmias.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06026475


Locations
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India
Anita Kulkarni
New Delhi, Please Select, India, 110078
Sponsors and Collaborators
Rajiv Gandhi Cancer Institute & Research Center, India
Investigators
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Principal Investigator: Anita Kulkarni, MD Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India
More Information
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Publications:

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Responsible Party: Dr Anita Kulkarni, Principal Investigator, Rajiv Gandhi Cancer Institute & Research Center, India
ClinicalTrials.gov Identifier: NCT06026475    
Other Study ID Numbers: RGCIRC-GDFT
First Posted: September 7, 2023    Key Record Dates
Last Update Posted: March 5, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Anita Kulkarni, Rajiv Gandhi Cancer Institute & Research Center, India:
Goal Directed Fluid Therapy
Stroke volume variation
Enhanced recovery after surgery