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

Yonsei University66 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Renal Mass

Interventions

Eligibility

Sex: ALLMin age: 20 YearsMax age: 79 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

postoperative renal function

Postoperative renal function measured by serum creatinine, cystatin C, and urine output

Time frame: for 3 days after surgery

Secondary Outcomes

systemic inflammatory response

the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP