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Ulinastatin reduces systemic inflammatory responses and protects organs from ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of ulinastatin on postoperative renal function in patients undergoing robot-assisted laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and control (n=35) groups. Randomly selected patients of the ulinastatin group are given ulinastatin. In contrast, patients in the control group receive an equivalent volume of normal saline as a placebo. The primary endpoints are postoperative renal function measured by serum creatinine, cystatin C, and urine output.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulinastatin group | Experimental | Patients in the ulinastatin group are given ulinastatin during operation. |
|
| control group | Placebo Comparator | Patients in the control group receive the same volume of normal saline during operation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ulinastatin | Drug |
| ||
| normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative renal function | Postoperative renal function measured by serum creatinine, cystatin C, and urine output | for 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| systemic inflammatory response | the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP | for 3 days after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital, Yonsei University College of Medicine | Seoul | South Korea |
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| ID | Term |
|---|---|
| C028665 | urinastatin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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