NCT01267786

Brief Summary

The aim of the study is to investigate the effect of sevoflurane and desflurane on hepatic function after ischemic/reperfusion injury and the sequence influence on renal and cardiovascular systems.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

December 1, 2010

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 29, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

December 29, 2010

Status Verified

December 1, 2010

Enrollment Period

1 year

First QC Date

December 28, 2010

Last Update Submit

December 28, 2010

Conditions

Keywords

Oxidotic stress

Outcome Measures

Primary Outcomes (1)

  • Oxidotic stress after hepatectomy.

    Perioperative liver and renal biopsies and follow up with liver renal function tests plus intraoperative and postoperative cardiovascular monitoring

    5 d postop.

Secondary Outcomes (1)

  • Liver and renal dysfunction

    5 d

Study Arms (2)

Sevoflurane

ACTIVE COMPARATOR

1MAC intraoperatively

Procedure: Liver surgery

desflurane

ACTIVE COMPARATOR

1 MAC intraoperatively

Procedure: Liver surgery

Interventions

Liver surgeryPROCEDURE

hepatectomy

Sevofluranedesflurane

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing liver surgery

You may not qualify if:

  • ASA IV, Cardiovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aretaieio Hospital

Athens, Attica, 115 28, Greece

RECRUITING

Study Officials

  • Georgios P Fragulidis, MD

    Areataieio Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Georgios P Fragulidis, MD

CONTACT

Aikaterini D Melemeni, MD, DESA

CONTACT

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2010

First Posted

December 29, 2010

Study Start

December 1, 2010

Primary Completion

December 1, 2011

Last Updated

December 29, 2010

Record last verified: 2010-12

Locations