MAP- Versus Cardiac Index-Guided Hemodynamic Management in Whipple Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAnkara Etlik City Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mean Arterial Pressure-Guided Hemodynamic Management
Procedure/SurgeryIntraoperative 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/SurgeryIntraoperative 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Mean Arterial Pressure-Guided Hemodynamic ManagementActive comparator 1 intervention
Group B: Cardiac Index-Guided Hemodynamic ManagementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 hourSecondary outcomes
1
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 surgery2
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 surgery3
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 hoursSponsors and contacts
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Source ClinicalTrials.gov