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

NCT ID: NCT02258906

Last Updated: 2016-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Mass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Ulinastatin group

Patients in the ulinastatin group are given ulinastatin during operation.

Group Type EXPERIMENTAL

ulinastatin

Intervention Type DRUG

control group

Patients in the control group receive the same volume of normal saline during operation.

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

Interventions

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ulinastatin

Intervention Type DRUG

normal saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0633

Identifier Type: -

Identifier Source: org_study_id

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