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

NCT02258906 — Not applicable, Completed, 66 participants, Yonsei University

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Registry	NCT02258906
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	66 (Actual)
Sponsor	Yonsei University (Other)
Conditions	Renal Mass
Interventions	ulinastatin, normal saline (Drug)
Dates	start 2014-10-01, primary completion 2016-07-01, completion 2016-07-01, first posted 2014-10-08, last updated 2016-08-25
Locations	1 site in South Korea

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Ulinastatin group	Experimental	Drug: ulinastatin	Patients in the ulinastatin group are given ulinastatin during operation.
control group	Placebo comparator	Drug: normal saline	Patients in the control group receive the same volume of normal saline during operation.

ulinastatin (Drug)
normal saline (Drug)

+Outcome measures

Primary outcomes

postoperative renal function [for 3 days after surgery]: Postoperative renal function measured by serum creatinine, cystatin C, and urine output

Secondary outcomes

systemic inflammatory response [for 3 days after surgery]: the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP

+Eligibility

Sex: All, ages: 20 Years to 79 Years

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

+Locations (1)

Facility	City	Country	Status
Severance Hospital, Yonsei University College of Medicine	Seoul	South Korea

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