Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressure in Major Abdominal Surgery Patients in the ICU.

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.

Study Overview

• Status: Recruiting
• Conditions: Elective Major Abdominal Surgery
• Intervention / Treatment: Procedure: Goal-Directed Fluid Therapy (GDFT)

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sidharta Kusuma Manggala, dr.; Phone Number: +6281281772295; Email: maninjau3@gmail.com

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Recruiting
      • Cipto Mangunkusumo hospital
      • Contact: Sidharta Kusuma Manggala, dr.; Phone Number: +6281281772295; Email: maninjau3@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A (Cardiac Index); During the first 6 hours postoperatively in the ICU, patients will receive fluid following a Goal-Directed Fluid Therapy (GDFT) protocol, with a target Cardiac Index of 2.5 to 4.0 L/min/m².	Procedure: Goal-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.
Active Comparator: Group B (Central Venous Pressure); During the first 6 hours postoperatively in the ICU, patients will receive fluid following a Goal-Directed Fluid Therapy (GDFT) protocol, with a target Central Venous Pressure (CVP) of 8-12 mmHg.	Procedure: Goal-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Intravenous Fluid Volume in the ICU	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).	From ICU enrollment until ICU discharge, up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	The occurrence of a relaparotomy procedure during the ICU stay, prior to step-down to a general ward.	From ICU enrollment until ICU discharge, up to 30 days
Reintubation	The occurrence of a reintubation during the ICU stay, prior to step-down to a general ward.	From ICU enrollment until ICU discharge, up to 30 days

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: November 29, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Estimated): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 29, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: intensive care; central venous pressure; goal-directed fluid therapy; cardiac index; elective major abdominal surgery; postoperative fluid management
• Other Study ID Numbers: 25-08-1273

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No