Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy

February 17, 2014 updated by: Yonsei University
Partial nephrectomy is a widely accepted alternative to radical nephrectomy in patients with clinically localized, unilateral renal cell carcinoma and a normal contralateral kidney. Interruption of renal blood flow via pedicle clamping is often necessary during partial nephrectomy, especially for complex tumors with deep parenchymal invasion. Ischemia-reperfusion injury is a complex process involving several mechanisms including renal vasoconstriction, extensive tubular damage and glomerular injury. The investigators will examine the postoperative renal function of patients who received intraoperative ketorolac and remote ischemic preconditioning during partial nephrectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA l and ll
  • age 20-65
  • patients undergoing partial nephrectomy

Exclusion Criteria:

  • preoperative liver or renal dysfunction,
  • coagulopathy,
  • chronic alcoholism,
  • hypersensitivity of NSAID,
  • history of warfarin,
  • history of gastric ulcer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Experimental: Keromin Group
Drug: Ketorolac tromethamine and remote ischemic preconditioning
Ketorolac tromethamine/ single / 1mg/kg/ intravenous administration 30 min before renal artery clamping, remote ischemic preconditioning / 200 mmHg / 5 min inflation and 10 min deflation / 3 cycles / after anesthetic induction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum creatinine
Time Frame: at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release

Secondary Outcome Measures

Outcome Measure
Time Frame
Creatinine clearance
Time Frame: at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
urinary NAG
Time Frame: at base line, 2 hr, 12 hr after clamping release
at base line, 2 hr, 12 hr after clamping release
serum NGAL
Time Frame: at base line, 2 hr, 12 hr after clamping release
at base line, 2 hr, 12 hr after clamping release

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 16, 2013

First Submitted That Met QC Criteria

April 18, 2013

First Posted (Estimate)

April 19, 2013

Study Record Updates

Last Update Posted (Estimate)

February 19, 2014

Last Update Submitted That Met QC Criteria

February 17, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2012-0485

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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