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

Ankara Etlik City Hospital60 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Whipple Procedure Intraoperative Hemodynamic Management

Interventions

Mean Arterial Pressure-Guided Hemodynamic ManagementPROCEDURE

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

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: Preoperative baseline and postoperative 72nd hour

Secondary Outcomes

Intraoperative urine output

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

Time frame: 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.

Time frame: 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.

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