Elective Major Abdominal SurgeryNCT07303855
Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressure in Major Abdominal Surgery Patients in the ICU.
A study testing Goal-Directed Fluid Therapy (GDFT) in people with Elective Major Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elective Major Abdominal Surgery
- What is being tested?
- Goal-Directed Fluid Therapy (GDFT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Dec 2025to 28 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Indonesia1 site, 1 recruiting
- Recruiting
Cipto Mangunkusumo Hospital
Jakarta Pusat, DKI Jakarta, 10430
Sidharta Kusuma Manggala, dr., +6281281772295, maninjau3@gmail.com
About this study
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.
- Conditions
- Elective Major Abdominal Surgery
- Being tested
- Goal-Directed Fluid Therapy (GDFT)
- Keywords
- cardiac index, central venous pressure, goal-directed fluid therapy, elective major abdominal surgery, postoperative fluid management, intensive care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal-Directed Fluid Therapy (GDFT)Procedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Cardiac Index) | Experimental | 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. Receives: Procedure: Goal-Directed Fluid Therapy (GDFT) |
| Group B (Central Venous Pressure) | Active comparator | 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. Receives: Procedure: Goal-Directed Fluid Therapy (GDFT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From ICU enrollment until ICU discharge, up to 30 days
Secondary outcomes (4)
ICU Mortality
Measured: From ICU enrollment until ICU discharge, up to 30 days
ICU Length of Stay
Measured: From ICU enrollment until ICU discharge, up to 30 days
Relaparotomy
The occurrence of a relaparotomy procedure during the ICU stay, prior to step-down to a general ward.
Measured: From ICU enrollment until ICU discharge, up to 30 days
Reintubation
The occurrence of a reintubation during the ICU stay, prior to step-down to a general ward.
Measured: From ICU enrollment until ICU discharge, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Dec 2025
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Major Abdominal SurgeryStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sidharta K. Manggala, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303855
- Sponsor's protocol ID
- 25-08-1273
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Goal-Directed Fluid Therapy Guided by Cardiac Index Versus Central Venous Pressure in Major Abdominal Surgery Patients in the ICU.
- ClinicalTrials.gov ID
- NCT07303855
- Acronym / sponsor ID
- 25-08-1273
- Conditions
- Elective Major Abdominal Surgery
- Keywords
- cardiac index, central venous pressure, goal-directed fluid therapy, elective major abdominal surgery, postoperative fluid management, intensive care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Cardiac Index) | Experimental | Procedure: Goal-Directed Fluid Therapy (GDFT)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. |
| Group B (Central Venous Pressure) | Active comparator | Procedure: Goal-Directed Fluid Therapy (GDFT)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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Group A (Cardiac Index), Group B (Central Venous Pressure) |
Primary outcome
Total Intravenous Fluid Volume in the ICU
Time frame: From ICU enrollment until ICU discharge, up to 30 days
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).
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal-Directed Fluid Therapy (GDFT) in people with Elective Major Abdominal Surgery, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sidharta Kusuma Manggala, dr. (+6281281772295, maninjau3@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Intravenous Fluid Volume in the ICU (time frame: From ICU enrollment until ICU discharge, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.