MAP- Versus Cardiac Index-Guided Hemodynamic Management in Colorectal Surgery
Comparison of the Effects of Mean Arterial Pressure-Based and Cardiac Index-Based Intraoperative Hemodynamic Management on Postoperative Renal Function in Patients Undergoing Colorectal Surgery: A Prospective Randomized Study
This prospective randomized trial aims to compare the effects of two intraoperative hemodynamic management strategies on early postoperative renal function in patients undergoing colorectal surgery. Patients will be randomly assigned to receive either mean arterial pressure-guided or cardiac index-guided intraoperative hemodynamic management.
Colorectal surgery is a major abdominal procedure associated with prolonged operative times, significant fluid shifts, blood loss, and hemodynamic instability. These factors can contribute to impaired renal perfusion and subsequent postoperative renal dysfunction. Although mean arterial pressure is widely used to guide intraoperative hemodynamic management, blood pressure alone may not adequately reflect systemic blood flow or regional 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 levels from the preoperative baseline to 72 hours postoperatively. Secondary outcomes include intraoperative hemodynamic variables, fluid and vasopressor requirements, urine output, postoperative renal function parameters, intensive care unit (ICU) and hospital length of stay, and 30-day mortality.
Studieoversikt
Status
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: İbrahim MD Topcu
- Telefonnummer: 00905437860316
- E-post: ibrahimtpc78@gmail.com
Studer Kontakt Backup
- Navn: Musa Ass. Prof Zengin
- Telefonnummer: 00905307716235
- E-post: musazengin@gmail.com
Studiesteder
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Yenimahalle\Ankara
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Ankara, Yenimahalle\Ankara, Tyrkia (Türkiye), 06170
- Rekruttering
- Ankara Etlik City Hospital
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Ta kontakt med:
- İbrahim MD Topcu
- Telefonnummer: 05437860316
- E-post: ibrahimtpc78@gmail.com
-
Ta kontakt med:
- Musa Assoc.Prof Zengin
- Telefonnummer: 00905307716235
- E-post: musazengin@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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 colorectal surgery
- 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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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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.
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Intraoperative hemodynamic management will be performed according to predefined cardiac index targets during colorectal surgery.
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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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 colorectal surgery.
Standard anesthetic care, fluid therapy, vasopressor use, and intraoperative monitoring will be applied according to institutional clinical practice.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in serum creatinine level from baseline to postoperative 72 hours
Tidsramme: : 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Intraoperative urine output
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AEŞH-EK-2026-132
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