NCT01132157

Brief Summary

Ischemia/reperfusion (IR) injury is the major cause of early renal dysfunction and acute renal failure of the transplanted kidney after renal transplantation. In 1986, Murry et al. described the phenomenon "ischemic preconditioning". Also, it was reported that a few non-ischemic stimuli could provide cellular tolerance against major ischemia through a mechanism similar to ischemic preconditioning. In an animal study, 1 minimal alveolar concentration of volatile anesthetics - a clinically relevant concentration - was reported to have a protective effect against ischemia/reperfusion injury, the effect being variable between types of anesthetics. Also, there were somm reports that intravenous anesthetics such as propofol could reduce IR injury by decreasing oxidative stress and apoptosis. By reducing the ischemia/reperfusion injury of the grafted kidney, the morbidity and mortality related to renal transplantation can be reduced as well. The objective of this study is to find out whether, according to the type of anesthetics (Desflurane vs. Propofol), there is a difference in the protective effect against ischemia/reperfusion injury of the grafted kidney in patients receiving renal transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
99

participants targeted

Target at P75+ for phase_4 healthy

Timeline
Completed

Started Mar 2010

Typical duration for phase_4 healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

1.8 years

First QC Date

May 24, 2010

Last Update Submit

March 4, 2014

Conditions

HealthyEnd Stage Renal Disease

Keywords

Healthy Kidney Donors and Their Recipients with End Stage Renal Disease

Outcome Measures

Primary Outcomes (4)

  • BUN(Blood Urea Nitrogen)

    The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.

    1 hour after surgery

  • Cr density

    The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.

    1 hour after surgery

  • estimated GFR(Glomerular Filtration Ratio)

    The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.

    1 hour after surgery

  • urine output to check the the degree of protection for renal function

    The primary outcome of our study is to find out whether, according to donors' anesthetics (desflurane or propofol), there is a difference in grafted kidney function postoperatively.

    1 hour after surgery

Study Arms (2)

Propofol group

EXPERIMENTAL
Drug: Propofol

Desflurane group

ACTIVE COMPARATOR
Drug: Desflurane

Interventions

DesfluraneDRUG

In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.

Desflurane group
PropofolDRUG

In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.

Propofol group

Eligibility Criteria

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

You may qualify if:

  • healthy kidney donors and their recipients of renal transplantation.

You may not qualify if:

  • a donor that has any medical or surgical history,
  • a recipient that is scheduled to have any other surgery with renal transplantation surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Severance hospital, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

DesfluranePropofol

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethyl EthersEthersOrganic ChemicalsMethyl EthersHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Officials

  • Bon Nyeo Koo, MD, Ph.D

    Severance Hospital, Yonsei University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2010

First Posted

May 27, 2010

Study Start

March 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

KR(1)