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

NCT02258906 · Yonsei University · Updated 25 Aug 2016

What is being tested
ulinastatin; normal saline
For
Renal Mass
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 20 years to 79 years. About 66 people. The full rules are on the registry page.
Where
South Korea
When
Starts or started Oct 2014, ends July 2016. Registered 8 Oct 2014.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT02258906

Sites

  • Severance Hospital, Yonsei University College of MedicineSeoul, South Korea