MAP- Versus Cardiac Index-Guided Hemodynamic Management in Whipple Surgery

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.

Study Overview

• Status: Recruiting
• Conditions: Whipple Procedure; Intraoperative Hemodynamic Management
• Intervention / Treatment: Procedure: Mean Arterial Pressure-Guided Hemodynamic Management; Procedure: Cardiac Index-Guided Hemodynamic Management

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Atakan Sezgi; Phone Number: 00905323327000; Email: kansezgi@gmail.com
• Study Contact Backup: Name: Musa Zengin; Phone Number: 00905307716235; Email: musazengin@gmail.com

Study Locations

• Turkey (Türkiye)
  • Ankara
    • Çankaya, Ankara, Turkey (Türkiye), 06170
      • Recruiting
      • Ankara Etlik City Hospital
      • Contact: Musa Zengin, Associate Professor; Phone Number: 00905307716235; Email: musazengin@gmail.com
      • Contact: Atakan Sezgi, M.D.; Phone Number: 00905323327000; Email: kansezgi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Mean Arterial Pressure-Guided Hemodynamic Management; 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.	Procedure: Mean Arterial Pressure-Guided Hemodynamic Management; 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.
Active Comparator: Cardiac Index-Guided Hemodynamic Management; 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.	Procedure: Cardiac Index-Guided Hemodynamic Management; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Preoperative baseline and postoperative 72nd hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative urine output	Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour.	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.	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.	Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours

Collaborators and Investigators

• Sponsor: Ankara Etlik City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2026
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): December 28, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cardiac index; Whipple procedure; Mean arterial pressure; Hemodynamic management
• Other Study ID Numbers: AEŞH-EK-2026-130

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No