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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01836406
First Posted: April 19, 2013
Last Update Posted: February 19, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yonsei University
  Purpose
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.

Condition Intervention
Renal Cell Carcinoma Drug: Ketorolac tromethamine and remote ischemic preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • serum creatinine [ Time Frame: at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release ]

Secondary Outcome Measures:
  • Creatinine clearance [ Time Frame: 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 ]
  • serum NGAL [ Time Frame: at base line, 2 hr, 12 hr after clamping release ]

Enrollment: 16
Study Start Date: December 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Group

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836406


Locations
Korea, Republic of
Severance hospital
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Yonsei University
  More Information

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01836406     History of Changes
Other Study ID Numbers: 4-2012-0485
First Submitted: April 16, 2013
First Posted: April 19, 2013
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Yonsei University:
ketorolac
remote ischemic preconditioning
partial nephrectomy

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Ketorolac
Ketorolac Tromethamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action