Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressu… (NCT07303855) | Clinical Trial Compass
RecruitingNot Applicable
Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressure in Major Abdominal Surgery Patients in the ICU.
Indonesia60 participantsStarted 2025-12-01
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total Intravenous Fluid Volume in the ICU
Timeframe: From ICU enrollment until ICU discharge, up to 30 days