Acute Renal InjuryNCT01807195
Acute Renal Injury Associated Contrast in Intensive Care Unit Patients
An observational study of Acute Renal Injury, run by Yonsei University at 1 site in South Korea.
Trial summary
Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Renal Injury
- What is being tested?
- contrast medium usage
- How many people
- 886 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2013to Feb 2014
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.
Who may be able to join
- For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined.
Who cannot join
- For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine
Seoul, Seoul, 120-752
About this study
Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.
- Conditions
- Acute Renal Injury
- Being tested
- contrast medium usage
- Keywords
- contrast, Intensive care unit, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast medium usageOther
| Study group | Role | What they receive |
|---|---|---|
| the medical records of those in whom a contrast medium | Not described Receives: Other: contrast medium usage |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of acute renal damage associated with contrast media in intensive care patients
The occurrence of acute renal damage was examined, and these patients were compared with the group that did not develop acute renal damage to investigate whether the use of contrast agents acts as an independent variable. In addition, the RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.
Measured: each time evaluation of contrast medium usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Renal InjuryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 only
- Time perspective
- Retrospective
- Enrolment
- 886 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01807195
- Sponsor's protocol ID
- 4-2012-0922
- Status last verified
- Jun 2014
- First submitted
- 6 Mar 2013
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Kim MH, Koh SO, Kim EJ, Cho JS, Na SW. Incidence and outcome of contrast-associated acute kidney injury assessed with Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients of medical and surgical intensive care units: a retrospective study. BMC Anesthesiol. 2015 Mar 3;15:23. doi: 10.1186/s12871-015-0008-x. eCollection 2015.
PubMed 25780349
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Renal Injury Associated Contrast in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01807195
- Acronym / sponsor ID
- 4-2012-0922
- Conditions
- Acute Renal Injury
- Keywords
- contrast, Intensive care unit, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 886 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 8 Mar 2013 (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.
Generally, a contrast medium is used when performing a CT scan or radiographic tests such as angiography because it heightens image clarity and can increase diagnosis accuracy. Despite these advantages, contrast media can cause allergic reactions in the body or a decline in renal function. Therefore, they should be handled carefully and explained sufficiently to the patient. For intensive care patients, the use of contrast agents has been revealed as a major cause of acute renal damage, and many studies have investigated this complication by examining incidence rates and prevention strategies. Hypothesis: Among intensive care patients, the group in which a contrast medium was used will have a higher risk of renal function decline compared with the group in which a contrast medium was not used, and, hence, the use of contrast media becomes a cause of renal function deterioration. Categorizing patients with renal function decline according to the new RIFLE criteria can have an association with the prognosis of intensive care patients, such as hospitalization period and death rate, which can promote faster intervention.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the medical records of those in whom a contrast medium | – | Other: contrast medium usage |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.
Key inclusion criteria (1 listed)
- For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was used in the intensive care unit were examined.
Key exclusion criteria (1 listed)
- For the 5 years from January 2008 to December 2012, patients in whom a contrast medium was not used in the intensive care unit were examined.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast medium usage | Other | the medical records of those in whom a contrast medium |
Primary outcome
The incidence of acute renal damage associated with contrast media in intensive care patients
Time frame: each time evaluation of contrast medium usage
The occurrence of acute renal damage was examined, and these patients were compared with the group that did not develop acute renal damage to investigate whether the use of contrast agents acts as an independent variable. In addition, the RIFLE (Risk, Injury, Failure, Loss, and End-stage kidney disease) categorization and the existing classification method were used to compare their predictive value for acute renal damage related to contrast media.
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 6 Jun 2014.
- Derived from this study: PubMed 25780349Kim MH, Koh SO, Kim EJ, Cho JS, Na SW. Incidence and outcome of contrast-associated acute kidney injury assessed with Risk, Injury, Failure, Loss, and End-stage kidney disease (RIFLE) criteria in critically ill patients of medical and surgical intensive care units: a retrospective study. BMC Anesthesiol. 2015 Mar 3;15:23. doi: 10.1186/s12871-015-0008-x. eCollection 2015.
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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 Acute Renal Injury, run by Yonsei University at 1 site in South Korea.
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 6 Jun 2014. 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 South Korea. 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?
The incidence of acute renal damage associated with contrast media in intensive care patients (time frame: each time evaluation of contrast medium usage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01807195, which also lists 1 linked publication.
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 6 Jun 2014.