Goal-directed IV fluid management using cardiac index versus central venous pressure after major abdominal surgery.
Official title: Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressure in Major Abdominal Surgery Patients in the ICU.
Run by Universitas Indonesia · NCT07303855 · Data updated 2026-11-12
This study will test whether guiding IV fluids by cardiac index or by central venous pressure during the first six hours in the ICU gives better fluid amounts and outcomes for adults after elective major abdominal surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Universitas Indonesia Academic / other |
| Locations | 1 site (Jakarta Pusat, DKI Jakarta) |
| Status | Recruiting |
| Started | December 1, 2025 |
| Main results expected | February 28, 2026 |
| Study ends | February 28, 2026 |
| Registry record updated | December 29, 2025 |
| Trial ID | NCT07303855 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18–65 years old with BMI 18–30 kg/m² undergoing elective major abdominal surgery with planned ICU admission and ASA physical status I–III are ideal candidates.
✕Probably not a fit
Patients with significant preoperative cardiovascular disease, severe renal impairment or dialysis dependence, non-sinus rhythms, right heart failure, suspected pulmonary hypertension, pregnancy, or those outside the age/BMI ranges are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adult patients having elective major abdominal surgery with planned ICU admission will receive goal-directed fluid therapy during the first six postoperative hours guided either by cardiac index or by central venous pressure. Total fluid volumes administered will be compared between the two approaches, along with outcomes such as mortality, ICU/hospital length of stay, relaparotomy, and reintubation. Patients are selected based on age, BMI, and ASA status, with several cardiovascular, renal, rhythm, and pregnancy exclusions. The trial is conducted at a single tertiary center and focuses on early postoperative hemodynamic management in the ICU.
Why it matters
Potential benefit: If successful, this approach could lead to more precise postoperative fluid management, fewer complications, and shorter ICU or hospital stays for eligible patients.
How similar studies have gone: Previous trials of goal-directed fluid therapy using cardiac output or dynamic measures have shown improved outcomes in some surgical groups compared with standard care, but direct comparisons with CVP-guided protocols in the postoperative ICU setting remain limited.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, Indonesia Recruiting
Study contacts
- Study coordinator: Sidharta Kusuma Manggala, dr.
- Email: maninjau3@gmail.com
- Phone: +6281281772295
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.