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Recruiting NCT07603336

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

No phase Interventional Whipple Procedure Intraoperative Hemodynamic Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mean Arterial Pressure-Guided Hemodynamic Management, Cardiac Index-Guided Hemodynamic Management.
Who it may be relevant to
Registry conditions: Whipple Procedure, Intraoperative Hemodynamic Management. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Pancreaticoduodenectomy: A Prospective Randomized Study

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.

Interventions

  • Procedure Mean Arterial Pressure-Guided Hemodynamic Management
    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.
  • Procedure Cardiac Index-Guided Hemodynamic Management
    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.

Primary outcome measures

  • Change in serum creatinine level from baseline to postoperative 72 hours [Time frame: Preoperative baseline and postoperative 72nd hour]
Secondary outcome measures (3)
  • Intraoperative urine output [Time frame: From anesthesia induction to the end of surgery]
  • Total intraoperative fluid administration [Time frame: From anesthesia induction to the end of surgery]
  • Postoperative serum creatinine levels [Time frame: Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Ankara Etlik City Hospital — Çankaya

Identifiers

NCT: NCT07603336 · AEŞH-EK-2026-130

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗