Elective Major Abdominal Surgery
Conditions
Keywords
cardiac index, central venous pressure, goal-directed fluid therapy, elective major abdominal surgery, postoperative fluid management, intensive care
Brief summary
This study aims to compare two different methods for guiding intravenous (IV) fluid therapy in patients during their first 6 hours in the ICU after major abdominal surgery. The goal is to determine which method leads to a more optimal and precise amount of fluid administration. The objective is to compare the total fluid volumes administered when guided by Cardiac Index versus Central Venous Pressure, as well as mortality, length of stay, relaparotomy and reintubation in order to identify the more precise fluid management strategy for postoperative ICU patients.
Interventions
PROCEDUREGoal-Directed Fluid Therapy (GDFT)
For the 6-hour intervention period, patients will receive fluid according to a Goal-Directed Fluid Therapy (GDFT) protocol. The treatment group will be managed to a target Cardiac Index of 2.5-4.0 L/min/m², while the control group will be managed to a target Central Venous Pressure (CVP) of 8-12 mmHg. All patients will receive a maintenance fluid volume of 25 mL/kg/24 hours, which will comprise the total volume from both parenteral fluids and enteral nutrition.
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients aged 18 to 65 years. * Patients with a Body Mass Index (BMI) between 18 and 30 kg/m². * Patients undergoing elective major abdominal surgery with a planned postoperative admission to the ICU. * Patients with an American Society of Anesthesiologists (ASA) physical status classification of I to III.
Exclusion criteria
* Patients with pre-operative cardiovascular disorders (Coronary Artery Disease, or heart failure NYHA Class III and IV). * Patients with severe renal impairment (Chronic Kidney Disease Stage V) with or without hemodialysis and fluid restrictions. * Non-sinus cardiac rhythm. * Pregnancy. * Patients with right heart failure (patients with signs of congestion and symptoms of right heart failure accompanied by evidence of reduced right ventricular function, indicated by TAPSE \< 17 mm). * Patients with pulmonary hypertension (patients with echocardiographic suspicion of tricuspid regurgitation, tricuspid regurgitation velocity \> 3.4 m/s, or mean pulmonary artery pressure \> 20 mmHg from right heart catheterization). * Patients with Acute Respiratory Distress Syndrome (ARDS) or patients requiring specialized ventilation modes. * Patients who refuse to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Intravenous Fluid Volume in the ICU | From ICU enrollment until ICU discharge, up to 30 days | The cumulative volume of intravenous fluids administered, recorded for both the initial 6-hour study period and the total ICU stay. Data will be obtained from ICU charts and recorded as a numerical value (mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU Mortality | From ICU enrollment until ICU discharge, up to 30 days | — |
| ICU Length of Stay | From ICU enrollment until ICU discharge, up to 30 days | — |
| Relaparotomy | From ICU enrollment until ICU discharge, up to 30 days | The occurrence of a relaparotomy procedure during the ICU stay, prior to step-down to a general ward. |
| Reintubation | From ICU enrollment until ICU discharge, up to 30 days | The occurrence of a reintubation during the ICU stay, prior to step-down to a general ward. |
Countries
Indonesia
Contacts
Primary ContactSidharta Kusuma Manggala, dr.
Outcome results
None listed