Oxidative StressNCT00965445
The Comparison of Oxidative Stress Between Inhalation Anesthetics
An observational study of Oxidative Stress and Cardiac Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress, Cardiac Surgery
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2007to Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients receiving cardiac valve surgery in Taipei Change Gung Memorial Hospital will be invited to participate this study
Who may be able to join
- patients receiving cardiac valve surgery in ASA II-III physical status
Who cannot join
- trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue.
Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.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 patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.
- Conditions
- Oxidative Stress, Cardiac Surgery
- Keywords
- isoprostanes, mass spectrometry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| cardiac surgery with CPB | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
isoprostanes isomer as marker of oxidative stress
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startMar 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yun-Hui Teng, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965445
- Sponsor's protocol ID
- CGMH-IRB-96-0019B
- Other IDs
- CGMH-IRB-96-0019B
- Status last verified
- Aug 2009
- First submitted
- 23 Aug 2009
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Oxidative Stress Between Inhalation Anesthetics
- ClinicalTrials.gov ID
- NCT00965445
- Acronym / sponsor ID
- CGMH-IRB-96-0019B
- Conditions
- Oxidative Stress, Cardiac Surgery
- Keywords
- isoprostanes, mass spectrometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Enhanced production of oxygen free radicals can lead to the generation of oxidative stress, which is harmful to human tissue and organs. Reactive oxygen species are released abruptly during some surgical procedures, and they are the major causes of ischemia-reperfusion injuries.Isoprostanes have been demonstrated to be a reliable biomarker for the evaluation of oxidative stress in vivo. Therefore, accurately monitoring and avoiding the occurrence of oxidative stress during surgery is an important clinical issue.
Isoprostanes are a series of prostaglandin-like compounds produced by non-enzymatic peroxidation of arachidonic acid.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 patients receiving a cardiac surgery (2)to investigate the change of isoprostanes after cardiopulmonary bypass (3)to investigate the effect of different anesthetics on isoprostanes during surgery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cardiac surgery with CPB | – | – |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving cardiac valve surgery in Taipei Change Gung Memorial Hospital will be invited to participate this study
Key inclusion criteria (1 listed)
- patients receiving cardiac valve surgery in ASA II-III physical status
Key exclusion criteria (1 listed)
- trauma, infection, low ejection fraction (less than 25%), liver cirrhosis, or acute renal failure, and emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
isoprostanes isomer as marker of oxidative stress
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Hui Teng, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress and Cardiac Surgery, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
isoprostanes isomer as marker of oxidative stress (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2009.