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

Fluid Loss Clinical Trial

— GDFT ERAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06026475
• Other study ID #: RGCIRC-GDFT
• Status: Completed
• Phase: N/A
• Start date: July 13, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: March 2024
• Source: Rajiv Gandhi Cancer Institute & Research Center, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Elective major open gastrointestinal Oncosurgeries .

Exclusion Criteria:

• Patient refusal.

• Robotic surgery.

• Laparoscopic surgery.

• Arrythmias.

Related Conditions & MeSH terms

• Enhanced Recovery
• Fluid Loss

Intervention

Procedure:
• Goal directed Fluid Therapy
Patients will receive fluid during surgery with goal of maintaining SVV below 11
• Conventional Fluid Therapy
Patients will receive fluid during surgery with goal of maintaining CVP between 8-12 cms H20

Locations

Country	Name	City	State
India	Anita Kulkarni	New Delhi	Please Select

Sponsors (1)

Lead Sponsor	Collaborator
Rajiv Gandhi Cancer Institute & Research Center, India

Country where clinical trial is conducted

India, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of ICU stay	Time of shifting of patients in both group to the ward in hours.	upto 5 days .
Primary	Postoperative serum Lactate levels mmol/L	Serum lactate levels will be measured in the SICU	upto 48 hours
Secondary	Serum Creatinine levels mg/dL.	Serum Creatinine levels will be measured in the SICU .	Upto 48 hours.