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NCT Number: NCT07603336

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

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.

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Key information

Conditions

Whipple Procedure Intraoperative Hemodynamic Management

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mean Arterial Pressure-Guided Hemodynamic Management

Procedure

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 Management

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Intraoperative urine output

    Time frame: From anesthesia induction to the end of surgery

    Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour.

  2. Total intraoperative fluid administration

    Time frame: From anesthesia induction to the end of surgery

    The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded.

  3. Postoperative serum creatinine levels

    Time frame: Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours

    Serum creatinine values will be recorded at predefined postoperative time points to evaluate renal function trends during the early postoperative period.

Study contacts

Contact information is provided by the study sponsor or research team.

Atakan Sezgi

CONTACT

[email protected]

00905323327000

Musa Zengin

CONTACT

[email protected]

00905307716235

Sponsors and collaborators

Lead sponsor

Ankara Etlik City Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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