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

Renal Cell Carcinoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836406
• Other study ID #: 4-2012-0485
• Status: Completed
• Phase: N/A
• First received: April 16, 2013
• Last updated: February 17, 2014
• Start date: December 2012
• Est. completion date: June 2013

Study information

• Verified date: February 2014
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Renal Cell Carcinoma
• Reperfusion Injury

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Severance hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum creatinine		at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release	No
Secondary	Creatinine clearance		at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release	No
Secondary	urinary NAG		at base line, 2 hr, 12 hr after clamping release	No
Secondary	serum NGAL		at base line, 2 hr, 12 hr after clamping release	No