Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy

Yonsei University

Status

Completed

Conditions

Renal Mass

Treatments

Drug: ulinastatin

Drug: normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02258906

4-2014-0633

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

20 to 79 years old

Volunteers

No Healthy Volunteers

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