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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06026475
Acronym
GDFT ERAS
Enrollment
60
Registered
2023-09-07
Start date
2023-07-13
Completion date
2024-01-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fluid Loss, Enhanced Recovery

Keywords

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

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.

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.

Interventions

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

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

Sponsors

Rajiv Gandhi Cancer Institute & Research Center, India
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Participant will be masked about allotment of interventional group either CVP or SVV .

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* Elective major open gastrointestinal Oncosurgeries .

Exclusion criteria

* Patient refusal. * Robotic surgery. * Laparoscopic surgery. * Arrythmias.

Design outcomes

Primary

MeasureTime frameDescription
Duration of ICU stayupto 5 days .Time of shifting of patients in both group to the ward in hours.
Postoperative serum Lactate levels mmol/Lupto 48 hoursSerum lactate levels will be measured in the SICU

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026