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

Ankara Etlik City Hospital

Status: Enrolling

Conditions: Whipple Procedure; Intraoperative Hemodynamic Management

Treatments: Procedure: Cardiac Index-Guided Hemodynamic Management; Procedure: Mean Arterial Pressure-Guided Hemodynamic Management

Study type: Interventional

Funder types: Other

Identifiers

NCT07603336

AEŞH-EK-2026-130

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Mean Arterial Pressure-Guided Hemodynamic Management

Active Comparator group

Description:

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.

Treatment:

Procedure: Mean Arterial Pressure-Guided Hemodynamic Management

Cardiac Index-Guided Hemodynamic Management

Active Comparator group

Description:

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.

Treatment:

Procedure: Cardiac Index-Guided Hemodynamic Management