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NCT Number: NCT07303855

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.

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Key information

Conditions

Elective Major Abdominal Surgery

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location status: Recruiting

Location contact

Sidharta Kusuma Manggala, dr.

CONTACT

[email protected]

+6281281772295

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Total Intravenous Fluid Volume in the ICU

    Time frame: 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 outcomes

  1. ICU Mortality

    Time frame: From ICU enrollment until ICU discharge, up to 30 days

  2. ICU Length of Stay

    Time frame: From ICU enrollment until ICU discharge, up to 30 days

  3. Relaparotomy

    Time frame: 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.

  4. Reintubation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sidharta Kusuma Manggala, dr.

CONTACT

[email protected]

+6281281772295

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 26, 2025
Registry last updated
Dec 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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