NCT00965445

Brief Summary

Oxidative stress is an unavoidable event during cardiac surgery. Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo.The aims of this study are(1)to develop an accurate liquid chromatography-tandem mass spectrometry methods for the detection of urinary isoprostane isomers in samples collected from healthy volunteers(for method quality control) and patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass(CPB) (3)to investigate the effect of different anesthetics on isoprostanes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2007

Shorter than P25 for all trials

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

March 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
Last Updated

August 26, 2009

Status Verified

August 1, 2009

Enrollment Period

9 months

First QC Date

August 23, 2009

Last Update Submit

August 24, 2009

Conditions

Oxidative StressCardiac Surgery

Keywords

isoprostanesmass spectrometry

Outcome Measures

Primary Outcomes (1)

  • isoprostanes isomer as marker of oxidative stress

    one day

Study Arms (1)

cardiac surgery with CPB

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients receiving cardiac valve surgery in Taipei Change Gung Memorial Hospital will be invited to participate this study

You may qualify if:

  • patients receiving cardiac valve surgery in ASA II-III physical status

You may not qualify if:

  • trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Anesthesiology, Chang Gung Memorial Hospital

Taipei, 105, Taiwan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

thirty milliliters of urine was collected from urine bag of patients at the following times: baseline before anesthesia, 30 minutes before cardiopulmonary bypass, during cardiopulmonary bypass, after the end of cardiopulmonary bypass.

Study Officials

  • Yun-Hui Teng, MD

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2009

First Posted

August 25, 2009

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 26, 2009

Record last verified: 2009-08

Locations

TW(1)