Kidney DiseasesNCT00632892
The Correlation Between Oxidative Stress and Indinated Contrast-Media Nephrotoxicity
An observational study of Kidney Diseases, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM. Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists, cardiologists, and radiologists. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Diseases
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2007to Jan 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Adult patients (> 18 years old) 2. Undergoing IVP with an appropriate medical indication 3. Signing informed consent
Who may be able to join
- Adult patients (> 18 years old)
- Undergoing IVP with an appropriate medical indication
- Signing informed consent
Who cannot join
- 1. Without signing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM. Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists, cardiologists, and radiologists.
The present study is aimed to determine the norepinephrine concentration, oxidative markers, and tubular damage markers in the urine samples of patients undergoing intravenous pyelography (IVP).
The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress and greater tubular damage than iso-osmolarity contrast media (IOCM).
- Conditions
- Kidney Diseases
- Keywords
- oxidative stress markers in urine, urine norepinephrine, renal tubular enzyme markers
- Medical subject headings
- Kidney Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startDec 2007
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseasesStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632892
- Sponsor's protocol ID
- 96013
- Status last verified
- Feb 2008
- First submitted
- 3 Mar 2008
- Last updated
- 11 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between Oxidative Stress and Indinated Contrast-Media Nephrotoxicity
- ClinicalTrials.gov ID
- NCT00632892
- Acronym / sponsor ID
- 96013
- Conditions
- Kidney Diseases
- Keywords
- oxidative stress markers in urine, urine norepinephrine, renal tubular enzyme markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Jan 2008 (actual)
- First posted
- 11 Mar 2008 (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.
Clinically, iodinated contrast-medium (CM) is widely used in angiography and computerized tomography. CM-induced nephropathy (CMIN) is one major complication after application of CM. Therefore, how to prevent CMIN is always one of the hot topics concerned by nephrologists, cardiologists, and radiologists.
The present study is aimed to determine the norepinephrine concentration, oxidative markers, and tubular damage markers in the urine samples of patients undergoing intravenous pyelography (IVP).
The working hypothesis is high-osmolarity contrast media (HOCM) causes more oxidative stress and greater tubular damage than iso-osmolarity contrast media (IOCM).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Adult patients (> 18 years old) 2. Undergoing IVP with an appropriate medical indication 3. Signing informed consent
Key inclusion criteria (3 listed)
- Adult patients (> 18 years old)
- Undergoing IVP with an appropriate medical indication
- Signing informed consent
Key exclusion criteria (1 listed)
- 1. Without signing informed consent
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
Not reported in the source record.
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 11 Mar 2008.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Kidney Diseases, run by Far Eastern 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 3 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 11 Mar 2008. 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.
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 11 Mar 2008.