RecruitingNot ApplicableNCT07603336

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


Sponsor

Ankara Etlik City Hospital

Enrollment

60 participants

Start Date

May 27, 2026

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria5

  • 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 Criteria5

  • 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

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Interventions

PROCEDUREMean 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.

PROCEDURECardiac 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.


Locations(1)

Ankara Etlik City Hospital

Çankaya, Ankara, Turkey (Türkiye)

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NCT07603336


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