Comparison of effect of crystalloids versus albumin for goal directed fluid therapy on peri-operative outcomes in major abdomino-pelvic oncological surgeries: a randomized control trial

Phase 2

Conditions: Health Condition 1: O- Medical and Surgical

Registration Number: CTRI/2024/02/063106

Lead Sponsor: Vasudha Ahuja

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

Patients aged >18 years, with American Society of Anesthesiology Physical Status (ASA PS) 1-3, scheduled to undergo elective major abdomino-pelvic oncological surgeries that are expected to last >2 hours.

patient undergoing surgery with expected blood loss > 300ml

Exclusion Criteria

age <18 years, Patient refusal, emergency surgery

Patients with decompensated ischemic heart disease, left ventricular ejection fraction <30%, cardiac arrhythmias, severe valvular heart disease

, preoperative creatinine > 2 mg/dl, renal failure, oliguria or anuria or on hemodialysis, coagulopathy, impaired liver function,

Pregnant and lactating patients.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post-operative morbidity survey score (POMS) on post-operative day 2Timepoint: Post-operative day 2

Secondary Outcome Measures

Name	Time	Method
Intraoperatively: HR, MAP, PPV, SVV, CI, total fluid administered, total number of fluid boluses, urine output, estimated blood loss, blood products transfused, total vasopressor requirement, inotrope requirement.Post-operatively: ABG, changes in coagulation profile & kidney function on POD – 0, 1, Length of stay in ICU/hospital, requirement of additional inotropic support, blood transfusion, incidence of complications during hospital admission.Timepoint: Intraoperatively: HR, MAP, PPV, SVV, CI measured every 15 minutes. Total fluid, urine output, blood loss measured hourly. Number of fluid boluses, blood products, vasopressor/inotrope requirement will be added at the end of the case. Post-operatively:ABG, coagulation profile & kidney function on POD-0&1.Length of stay in ICU/hospital, inotropic support, blood transfusion, post-operative complications will be noted throughout hospital stay.