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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mean Arterial Pressure-Guided Hemodynamic Management | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative urine output | Hourly urine output will be recorded intraoperatively and expressed as mL/kg/hour. | From anesthesia induction to the end of surgery |
| Total intraoperative fluid administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| İbrahim MD Topcu | Contact | 00905437860316 | ibrahimtpc78@gmail.com | |
| Musa Ass. Prof Zengin | Contact | 00905307716235 | musazengin@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara Etlik City Hospital | Recruiting | Ankara | Yenimahalle\Ankara | 06170 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| Cardiac Index-Guided Hemodynamic Management | Procedure | 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. |
|
The total amount of crystalloid and colloid fluids administered intraoperatively will be recorded.
| From anesthesia induction to the end of surgery |
| Postoperative serum creatinine levels | Serum creatinine values will be recorded at predefined postoperative time points to evaluate renal function trends during the early postoperative period. | Postoperative 0-6 hours, 24 hours, 48 hours, and 72 hours |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |