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

ConditionElective Major Abdominal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorIndonesia University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Goal-Directed Fluid Therapy (GDFT)

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group A (Cardiac Index)Experimental treatment 1 intervention
Group B: Group B (Central Venous Pressure)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Intravenous Fluid Volume in the ICU

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).

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

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

The occurrence of a relaparotomy procedure during the ICU stay, prior to step-down to a general ward.

Time frame
From ICU enrollment until ICU discharge, up to 30 days
4

Reintubation

The occurrence of a reintubation during the ICU stay, prior to step-down to a general ward.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indonesia University

Lead sponsor

Source ClinicalTrials.gov
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