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

NCT07303855 | Recruiting

• 1 other identifier: 25-08-1273
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Elective Major Abdominal Surgery

Keywords

cardiac index; central venous pressure; goal-directed fluid therapy; elective major abdominal surgery; postoperative fluid management; intensive care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• Reintubation

  From ICU enrollment until ICU discharge, up to 30 days

Study Arms (2)

Group A (Cardiac Index)

EXPERIMENTAL

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)

Group B (Central Venous Pressure)

ACTIVE COMPARATOR

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)

Interventions

Goal-Directed Fluid Therapy (GDFT) PROCEDURE

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.

Group A (Cardiac Index); Group B (Central Venous Pressure)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

Central Study Contacts

Sidharta Kusuma Manggala, dr.

CONTACT

+6281281772295; maninjau3@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 29, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)