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

Sponsor

Rajiv Gandhi Cancer Institute & Research Center, India (Other)

Overall Status

Recruiting

CT.gov ID

NCT06026475

Collaborator

(none)

Enrollment

Location

Arms

4.6

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Study Type:

Interventional

Anticipated 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.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 :

Jul 13, 2023

Anticipated Primary Completion Date :

Nov 17, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

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

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

Primary Outcome Measures

Duration of ICU stay [upto 5 days .]
Time of shifting of patients in both group to the ward in hours.
Postoperative serum Lactate levels mmol/L [upto 48 hours]
Serum lactate levels will be measured in the SICU

Secondary Outcome Measures

Serum Creatinine levels mg/dL. [Upto 48 hours.]
Serum Creatinine levels will be measured in the SICU .

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Elective major open gastrointestinal Oncosurgeries .

Exclusion Criteria:

Patient refusal.
Robotic surgery.
Laparoscopic surgery.
Arrythmias.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anita Kulkarni	New Delhi	Please Select	India	110078

Sponsors and Collaborators

Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

Principal Investigator: Anita Kulkarni, MD, Rajiv Gandhi Cancer Institute and Research Centre , Delhi , India

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

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:

Sep 7, 2023

Last Update Posted:

Sep 7, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Dr Anita Kulkarni, Principal Investigator, Rajiv Gandhi Cancer Institute & Research Center, India

Goal Directed Fluid Therapy

Stroke volume variation

Enhanced recovery after surgery

Study Results

No Results Posted as of Sep 7, 2023