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

• Sponsor: Yonsei University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02258906
• Collaborator: (none)
• Enrollment: 66
• Location: 1
• Arms: 2
• Duration (Months): 21
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Mass	Drug: ulinastatin; Drug: normal saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Prevention
• Official Title: Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ulinastatin group Patients in the ulinastatin group are given ulinastatin during operation.	Drug: ulinastatin
Placebo Comparator: control group Patients in the control group receive the same volume of normal saline during operation.	Drug: normal saline

Outcome Measures

Primary Outcome Measures

1. postoperative renal function [for 3 days after surgery]

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

Secondary Outcome Measures

1. systemic inflammatory response [for 3 days after surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 79 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yonsei University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yonsei University
• ClinicalTrials.gov Identifier: NCT02258906
• Other Study ID Numbers: 4-2014-0633
• First Posted: Oct 8, 2014
• Last Update Posted: Aug 25, 2016
• Last Verified: Aug 1, 2016

• Additional relevant MeSH terms: Urinastatin

Study Results

No Results Posted as of Aug 25, 2016