Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07603336

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

Led by Ankara Etlik City Hospital · Updated on 2026-05-28

60

Participants Needed

1

Research Sites

2 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods of managing blood flow during pancreaticoduodenectomy, a major surgery known as the Whipple procedure. The study evaluates whether managing blood pressure by mean arterial pressure or by cardiac index better supports kidney function shortly after surgery. This prospective randomized study focuses on changes in kidney function, measured by serum creatinine levels, within the first 72 hours after the operation. Participants will be randomly assigned to one of two groups during surgery. One group will have their blood flow managed by keeping mean arterial pressure within target ranges, guiding fluid and medication use accordingly. The other group will have management based on cardiac index targets, adjusting fluids, vasopressors, and inotropes to maintain adequate circulatory status. Both groups receive standard anesthesia care during the pancreaticoduodenectomy. Throughout the study, researchers will monitor kidney function by measuring serum creatinine before surgery and at several points after, including 6, 24, 48, and 72 hours post-operation. They will also track urine output, fluid given during surgery, medication use, and hospital recovery details such as intensive care and total hospital stay lengths. The study aims to understand which management method better preserves kidney function after this complex surgery, with participants involved from surgery through early recovery assessments.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 m
  • Patients scheduled for pancreaticoduodenectomy / Whipple procedure
  • Patients who provide written informed consent
Not Eligible

You will not qualify if you...

  • Patients younger than 18 years or older than 80 years
  • Patients with estimated glomerular filtration rate <60 mL/min/1.73 m
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and immediate post-operative period

Participants undergo pancreaticoduodenectomy (Whipple surgery) with intraoperative hemodynamic management guided by either mean arterial pressure or cardiac index targets. Standard anesthetic care, fluid therapy, and vasopressor use are applied during surgery.

1 surgical procedure day visit

Post-operative Follow-up

Duration - 72 hours after surgery

Participants are monitored postoperatively to assess renal function and other outcomes related to the surgery and hemodynamic management.

Visits at 0-6 hours, 24 hours, 48 hours, and 72 hours post-surgery

Trial Site Locations

Total: 1 location

1

Ankara Etlik City Hospital

Çankaya, Ankara, Turkey (Türkiye), 06170

Actively Recruiting

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Research Team

A

Atakan Sezgi

M

Musa Zengin

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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