Renal Mass
Conditions
Brief summary
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.
Interventions
DRUGulinastatin
DRUGnormal saline
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
20 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy with an American Society of Anesthesiologists (ASA) physical status I-III
Exclusion criteria
* Subjects are ineligible if they have severe respiratory or cardiovascular disease, renal insufficiency before operation, cognitive dysfunction, are unable to communicate or speak Korean
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative renal function | for 3 days after surgery | Postoperative renal function measured by serum creatinine, cystatin C, and urine output |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| systemic inflammatory response | for 3 days after surgery | the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP |
Countries
South Korea
Outcome results
None listed