Ireland
--:--IST
Recruiting Not applicable

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

NCT07603336 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2026-05-27
Last updated
2026-05-28

Condition(s) studied

Whipple ProcedureIntraoperative Hemodynamic Management

Investigational drug(s) / intervention(s)

Mean Arterial Pressure-Guided Hemodynamic ManagementCardiac Index-Guided Hemodynamic Management

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.

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Change in serum creatinine level from baseline to postoperative 72 hours — 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.

Trial sites (1)

FacilityCityRegionStatus
Ankara Etlik City Hospital Çankaya Ankara Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07603336 on ClinicalTrials.gov ↗ ← All trials in Turkey