NCT01836406

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2012

Shorter than P25 for not_applicable

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

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

February 19, 2014

Status Verified

February 1, 2014

Enrollment Period

6 months

First QC Date

April 16, 2013

Last Update Submit

February 17, 2014

Conditions

Renal Cell Carcinoma

Keywords

ketorolacremote ischemic preconditioningpartial nephrectomy

Outcome Measures

Primary Outcomes (1)

  • serum creatinine

    at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release

Secondary Outcomes (3)

  • Creatinine clearance

    at baseline, 2 hr, 12hr, 24 hr, 48 hr, 72 hr after clamping release

  • urinary NAG

    at base line, 2 hr, 12 hr after clamping release

  • serum NGAL

    at base line, 2 hr, 12 hr after clamping release

Study Arms (2)

Keromin Group

EXPERIMENTAL
Drug: Ketorolac tromethamine and remote ischemic preconditioning

Placebo Group

PLACEBO COMPARATOR

Interventions

Ketorolac tromethamine and remote ischemic preconditioningDRUG

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

Keromin Group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital

Seoul, Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Ketorolac Tromethamine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

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

Study Record Dates

First Submitted

April 16, 2013

First Posted

April 19, 2013

Study Start

December 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

February 19, 2014

Record last verified: 2014-02

Locations

KR(1)