Intraoperative Hemodynamic Management, Whipple Procedure
Conditions
Keywords
Whipple procedure, Cardiac index, Mean arterial pressure, Hemodynamic management
Brief 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.
Interventions
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.
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.
Sponsors
Ankara Etlik City Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative urine output | From anesthesia induction to the end of surgery | Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour. |
| Total intraoperative fluid administration | From anesthesia induction to the end of surgery | The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded. |
| Postoperative serum creatinine levels | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTAtakan Sezgi
CONTACTMusa Zengin
Outcome results
None listed