Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07303855

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

Led by Indonesia University · Updated on 2025-12-29

60

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Cipto Mangunkusumo Hospital

Jakarta Pusat, DKI Jakarta, Indonesia, 10430

Actively Recruiting

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Research Team

S

Sidharta Kusuma Manggala, dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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