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

Primary Purpose

Renal Cell Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ketorolac tromethamine and remote ischemic preconditioning
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Renal Cell Carcinoma focused on measuring ketorolac, remote ischemic preconditioning, partial nephrectomy

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Keromin Group

Placebo Group

Arm Description

Outcomes

Primary Outcome Measures

serum creatinine

Secondary Outcome Measures

Creatinine clearance
urinary NAG
serum NGAL

Full Information

First Posted
April 16, 2013
Last Updated
February 17, 2014
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT01836406
Brief Title
Effect of Ketorolac and Remote Ischemic Preconditioning on Renal Ischemia-reperfusion Injury in Patients Undergoing Partial Nephrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Cell Carcinoma
Keywords
ketorolac, remote ischemic preconditioning, partial nephrectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keromin Group
Arm Type
Experimental
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ketorolac tromethamine and remote ischemic preconditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
serum creatinine
Time Frame
at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
Secondary Outcome Measure Information:
Title
Creatinine clearance
Time Frame
at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release
Title
urinary NAG
Time Frame
at base line, 2 hr, 12 hr after clamping release
Title
serum NGAL
Time Frame
at base line, 2 hr, 12 hr after clamping release

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

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

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