NCT02258906

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 25, 2016

Status Verified

August 1, 2016

Enrollment Period

1.8 years

First QC Date

October 2, 2014

Last Update Submit

August 23, 2016

Conditions

Renal Mass

Outcome Measures

Primary Outcomes (1)

  • postoperative renal function

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

    for 3 days after surgery

Secondary Outcomes (1)

  • systemic inflammatory response

    for 3 days after surgery

Study Arms (2)

Ulinastatin group

EXPERIMENTAL

Patients in the ulinastatin group are given ulinastatin during operation.

Drug: ulinastatin

control group

PLACEBO COMPARATOR

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

Drug: normal saline

Interventions

ulinastatinDRUG
Ulinastatin group
normal salineDRUG
control group

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy with an American Society of Anesthesiologists (ASA) physical status I-III

You may not qualify if:

  • Subjects are ineligible if they have severe respiratory or cardiovascular disease, renal insufficiency before operation, cognitive dysfunction, are unable to communicate or speak Korean

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance Hospital, Yonsei University College of Medicine

Seoul, South Korea

Location

MeSH Terms

Interventions

urinastatinSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 2, 2014

First Posted

October 8, 2014

Study Start

October 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

August 25, 2016

Record last verified: 2016-08

Locations

KR(1)