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Recruiting NCT07303855

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

No phase Interventional Elective Major Abdominal Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Goal-Directed Fluid Therapy (GDFT).
Who it may be relevant to
Registry conditions: Elective Major Abdominal Surgery. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Indonesia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Total Intravenous Fluid Volume in the ICU [Time frame: From ICU enrollment until ICU discharge, up to 30 days]
Secondary outcome measures (4)
  • ICU Mortality [Time frame: From ICU enrollment until ICU discharge, up to 30 days]
  • ICU Length of Stay [Time frame: From ICU enrollment until ICU discharge, up to 30 days]
  • Relaparotomy [Time frame: From ICU enrollment until ICU discharge, up to 30 days]
  • Reintubation [Time frame: From ICU enrollment until ICU discharge, up to 30 days]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

Indonesia · 1 center
  • Cipto Mangunkusumo Hospital — Jakarta Pusat

Identifiers

NCT: NCT07303855 · 25-08-1273

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗