Whipple ProcedureNCT07603336
MAP- Versus Cardiac Index-Guided Hemodynamic Management in Whipple Surgery
A study testing Mean Arterial Pressure-Guided Hemodynamic Management and Cardiac Index-Guided Hemodynamic Management in people with Whipple Procedure and Intraoperative Hemodynamic Management, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized study aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing pancreaticoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Whipple Procedure, Intraoperative Hemodynamic Management
- What is being tested?
- Mean Arterial Pressure-Guided Hemodynamic Management and Cardiac Index-Guided Hemodynamic Management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2026to 28 Dec 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 80 years
- Patients with American Society of Anesthesiologists physical status II-III
- Patients with estimated glomerular filtration rate ≥60 mL/min/1.73 m²
- Patients scheduled for pancreaticoduodenectomy / Whipple procedure
- Patients who provide written informed consent
Who cannot join
- Patients younger than 18 years or older than 80 years
- Patients with estimated glomerular filtration rate <60 mL/min/1.73 m²
- Patients with American Society of Anesthesiologists physical status other than II-III
- Patients who refuse to participate in the study
- Patients who withdraw consent at any stage of 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.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Etlik City Hospital
Çankaya, Ankara, 06170
Atakan Sezgi, M.D., 00905323327000, kansezgi@gmail.com
Musa Zengin, Associate Professor, 00905307716235, musazengin@gmail.com
About this study
Official title: Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Study
This prospective randomized study aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing pancreaticoduodenectomy. Patients will be allocated to either mean arterial pressure-guided hemodynamic management or cardiac index-guided hemodynamic management during surgery.
Pancreaticoduodenectomy is a major abdominal surgical procedure associated with prolonged operative duration, considerable fluid shifts, blood loss, and hemodynamic instability. These factors may contribute to impaired renal perfusion and postoperative renal dysfunction. Although mean arterial pressure is commonly used to guide intraoperative hemodynamic management, blood pressure alone may not fully reflect systemic blood flow or tissue perfusion. Cardiac index-guided management may provide a more direct assessment of global circulatory adequacy.
The primary outcome of the study is the change in serum creatinine level from the preoperative baseline value to the postoperative 72nd hour. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, length of intensive care unit and hospital stay, and 30-day mortality.
- Being tested
- Mean Arterial Pressure-Guided Hemodynamic Management, Cardiac Index-Guided Hemodynamic Management
- Keywords
- Whipple procedure, Cardiac index, Mean arterial pressure, Hemodynamic management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mean Arterial Pressure-Guided Hemodynamic ManagementProcedure or surgery
Intraoperative hemodynamic management will be performed according to predefined mean arterial pressure targets during pancreaticoduodenectomy. Standard anesthetic care, fluid therapy, vasopressor use, and intraoperative monitoring will be applied according to institutional clinical practice.
Cardiac Index-Guided Hemodynamic ManagementProcedure or surgery
Intraoperative hemodynamic management will be performed according to predefined cardiac index targets during pancreaticoduodenectomy. Cardiac index values will be monitored intraoperatively, and fluid therapy, vasopressor use, and inotrope administration will be adjusted according to the hemodynamic status of the patient and institutional clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Mean Arterial Pressure-Guided Hemodynamic Management | Active comparator | Patients in this group will receive intraoperative hemodynamic management based on predefined mean arterial pressure targets. Hemodynamic interventions, including fluid administration, vasopressor therapy, and other standard intraoperative management strategies, will be guided primarily by mean arterial pressure values. Receives: Procedure: Mean Arterial Pressure-Guided Hemodynamic Management |
| Cardiac Index-Guided Hemodynamic Management | Active comparator | Patients in this group will receive intraoperative hemodynamic management based on predefined cardiac index targets. Hemodynamic interventions, including fluid administration, vasopressor or inotrope therapy, and other standard intraoperative management strategies, will be guided primarily by cardiac index values. Receives: Procedure: Cardiac Index-Guided Hemodynamic Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum creatinine level from baseline to postoperative 72 hours
The primary outcome is the change in serum creatinine level, calculated as the difference between the serum creatinine value measured at postoperative 72 hours and the preoperative baseline serum creatinine value.
Measured: Preoperative baseline and postoperative 72nd hour
Secondary outcomes (3)
Intraoperative urine output
Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour.
Measured: From anesthesia induction to the end of surgery
Total intraoperative fluid administration
The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded.
Measured: From anesthesia induction to the end of surgery
Postoperative serum creatinine levels
Serum creatinine values will be recorded at predefined postoperative time points to evaluate renal function trends during the early postoperative period.
Measured: Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start27 May 2026
- Primary completion14 Dec 2027 (estimated)
- Study completion28 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whipple ProcedureStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Atakan Sezgi, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603336
- Sponsor's protocol ID
- AEŞH-EK-2026-130
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07603336
- Acronym / sponsor ID
- AEŞH-EK-2026-130
- Keywords
- Whipple procedure, Cardiac index, Mean arterial pressure, Hemodynamic management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 27 May 2026 (actual)
- Primary completion
- 14 Dec 2027 (estimated)
- Study completion
- 28 Dec 2027 (estimated)
- First posted
- 22 May 2026 (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 prospective randomized study aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing pancreaticoduodenectomy. Patients will be allocated to either mean arterial pressure-guided hemodynamic management or cardiac index-guided hemodynamic management during surgery.
Pancreaticoduodenectomy is a major abdominal surgical procedure associated with prolonged operative duration, considerable fluid shifts, blood loss, and hemodynamic instability. These factors may contribute to impaired renal perfusion and postoperative renal dysfunction. Although mean arterial pressure is commonly used to guide intraoperative hemodynamic management, blood pressure alone may not fully reflect systemic blood flow or tissue perfusion. Cardiac index-guided management may provide a more direct assessment of global circulatory adequacy.
The primary outcome of the study is the change in serum creatinine level from the preoperative baseline value to the postoperative 72nd hour. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, length of intensive care unit and hospital stay, and 30-day mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mean Arterial Pressure-Guided Hemodynamic Management | Active comparator | Procedure: Mean Arterial Pressure-Guided Hemodynamic ManagementPatients in this group will receive intraoperative hemodynamic management based on predefined mean arterial pressure targets. Hemodynamic interventions, including fluid administration, vasopressor therapy, and other standard intraoperative management strategies, will be guided primarily by mean arterial pressure values. |
| Cardiac Index-Guided Hemodynamic Management | Active comparator | Procedure: Cardiac Index-Guided Hemodynamic ManagementPatients in this group will receive intraoperative hemodynamic management based on predefined cardiac index targets. Hemodynamic interventions, including fluid administration, vasopressor or inotrope therapy, and other standard intraoperative management strategies, will be guided primarily by cardiac index values. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 to 80 years
- Patients with American Society of Anesthesiologists physical status II-III
- Patients with estimated glomerular filtration rate ≥60 mL/min/1.73 m²
- Patients scheduled for pancreaticoduodenectomy / Whipple procedure
- Patients who provide written informed consent
Key exclusion criteria (5 listed)
- Patients younger than 18 years or older than 80 years
- Patients with estimated glomerular filtration rate <60 mL/min/1.73 m²
- Patients with American Society of Anesthesiologists physical status other than II-III
- Patients who refuse to participate in the study
- Patients who withdraw consent at any stage of the study
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 |
|---|---|---|
| Mean Arterial Pressure-Guided Hemodynamic ManagementIntraoperative hemodynamic management will be performed according to predefined mean arterial pressure targets during pancreaticoduodenectomy. Standard anesthetic care, fluid therapy, vasopressor use, and intraoperative monitoring will be applied according to institutional clinical practice. | Procedure or surgery | Mean Arterial Pressure-Guided Hemodynamic Management |
| Cardiac Index-Guided Hemodynamic ManagementIntraoperative hemodynamic management will be performed according to predefined cardiac index targets during pancreaticoduodenectomy. Cardiac index values will be monitored intraoperatively, and fluid therapy, vasopressor use, and inotrope administration will be adjusted according to the hemodynamic status of the patient and institutional clinical practice. | Procedure or surgery | Cardiac Index-Guided Hemodynamic Management |
Primary outcome
Change in serum creatinine level from baseline to postoperative 72 hours
Time frame: Preoperative baseline and postoperative 72nd hour
The primary outcome is the change in serum creatinine level, calculated as the difference between the serum creatinine value measured at postoperative 72 hours and the preoperative baseline serum creatinine value.
3 secondary outcomes
Intraoperative urine output
Time frame: From anesthesia induction to the end of surgery
Total intraoperative fluid administration
Time frame: From anesthesia induction to the end of surgery
Postoperative serum creatinine levels
Time frame: Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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 28 May 2026.
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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 Mean Arterial Pressure-Guided Hemodynamic Management and Cardiac Index-Guided Hemodynamic Management in people with Whipple Procedure and Intraoperative Hemodynamic Management, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 28 May 2026. 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 Turkey (Türkiye). 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 Atakan Sezgi (00905323327000, kansezgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum creatinine level from baseline to postoperative 72 hours (time frame: Preoperative baseline and postoperative 72nd hour). 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 28 May 2026.