MAP- Versus Cardiac Index-Guided Hemodynamic Management in Whipple Surgery
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
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.
Studieöversikt
Status
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Atakan Sezgi
- Telefonnummer: 00905323327000
- E-post: kansezgi@gmail.com
Studera Kontakt Backup
- Namn: Musa Zengin
- Telefonnummer: 00905307716235
- E-post: musazengin@gmail.com
Studieorter
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Ankara
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Çankaya, Ankara, Turkiet (Türkiye), 06170
- Rekrytering
- Ankara Etlik City Hospital
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Kontakt:
- Musa Zengin, Associate Professor
- Telefonnummer: 00905307716235
- E-post: musazengin@gmail.com
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Kontakt:
- Atakan Sezgi, M.D.
- Telefonnummer: 00905323327000
- E-post: kansezgi@gmail.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Mean Arterial Pressure-Guided Hemodynamic Management
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.
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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.
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Aktiv komparator: Cardiac Index-Guided Hemodynamic Management
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.
|
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in serum creatinine level from baseline to postoperative 72 hours
Tidsram: Preoperative baseline and postoperative 72nd hour
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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.
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Preoperative baseline and postoperative 72nd hour
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Intraoperative urine output
Tidsram: From anesthesia induction to the end of surgery
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Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour.
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From anesthesia induction to the end of surgery
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Total intraoperative fluid administration
Tidsram: From anesthesia induction to the end of surgery
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The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded.
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From anesthesia induction to the end of surgery
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Postoperative serum creatinine levels
Tidsram: Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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Serum creatinine values will be recorded at predefined postoperative time points to evaluate renal function trends during the early postoperative period.
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Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- AEŞH-EK-2026-130
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