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

University of Indonesia (UI)

Status: Enrolling

Conditions: Elective Major Abdominal Surgery

Treatments: Procedure: Goal-Directed Fluid Therapy (GDFT)

Study type: Interventional

Funder types: Other

Identifiers

NCT07303855

25-08-1273

Details and patient eligibility

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group A (Cardiac Index)

Experimental group

Description:

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.

Treatment:

Procedure: Goal-Directed Fluid Therapy (GDFT)

Group B (Central Venous Pressure)

Active Comparator group

Description:

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.

Treatment:

Procedure: Goal-Directed Fluid Therapy (GDFT)