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

NCT07603336 | Not Yet Recruiting

• 1 other identifier: AEŞH-EK-2026-130
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Whipple Procedure; Intraoperative Hemodynamic Management

Keywords

Whipple procedure; Cardiac index; Mean arterial pressure; Hemodynamic management

Outcome Measures

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.

  Preoperative baseline and postoperative 72nd hour

Secondary Outcomes (3)

• Intraoperative urine output

  From anesthesia induction to the end of surgery

• Total intraoperative fluid administration

  From anesthesia induction to the end of surgery

• Postoperative serum creatinine levels

  Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours

Study Arms (2)

Mean Arterial Pressure-Guided Hemodynamic Management

ACTIVE COMPARATOR

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.

Procedure: Mean Arterial Pressure-Guided Hemodynamic Management

Cardiac Index-Guided Hemodynamic Management

ACTIVE COMPARATOR

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.

Procedure: Cardiac Index-Guided Hemodynamic Management

Interventions

Mean Arterial Pressure-Guided Hemodynamic Management PROCEDURE

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.

Mean Arterial Pressure-Guided Hemodynamic Management

Cardiac Index-Guided Hemodynamic Management PROCEDURE

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.

Cardiac Index-Guided Hemodynamic Management

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Etlik City Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Çankaya, Ankara, 06170, Turkey (Türkiye)

Location

Central Study Contacts

Atakan Sezgi

CONTACT

00905323327000; kansezgi@gmail.com

Musa Zengin

CONTACT

00905307716235; musazengin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 14, 2027
• Study Completion (Estimated): December 28, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

TU (1)