RecruitingNot ApplicableNCT07303855

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


Sponsor

Indonesia University

Enrollment

60 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria8

  • 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.

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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.


Locations(1)

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

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NCT07303855


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