Acute Kidney FailureIDPCNCT02991742
Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients (IDPC Trial)
An observational study of Acute Kidney Failure, run by Instituto Dante Pazzanese de Cardiologia.
Trial summary
Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- contrast media
- How many people
- 2,262 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Nov 2020
- 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: Patients undergoing coronary angiography or percutaneous interventions will be eligible for the trial if they have at least 1 risk factor for contrast-induced acute kidney injury
Who may be able to join
- At least one of the following criteria
- Aged more than 70 years-old
- Chronic renal failure
- Diabetes mellitus
- Congestive heart failure - left ventricular ejection fraction < 0.50
- Shock or intra-aortic ballon pump use
- Urgency or emergency procedures
Who cannot join
- Patients in dialysis
- Allergy to iodine
- Patient refusal to informed consent
About this study
Official title: Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients After Diagnostic and Therapeutic Cardiac Catheterization (IDPC Trial)
Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.
Read the detailed description
Contrast-induced acute kidney injury represents a serious complication of procedures requiring administration of iodinated contrast media and is associated with the need for dialysis, prolonged hospitalization, increased costs, and mortality.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than low-osmolar contrast media in high-risk patients.
The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients between 48 and 96 hours after procedures that use contrast.
- Conditions
- Acute Kidney Failure
- Being tested
- contrast media
- Keywords
- nephropathy, catheterization, contrast media, ioxaglate, iodixanol, high risk, prevention
- Medical subject headings
- Acute Kidney Injury, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
contrast mediaOther
Also called Iodixanol X Ioxaglate
Compare 2 contrast media
| Study group | Role | What they receive |
|---|---|---|
| Iodixanol | Iodixanol contrast media Receives: Other: contrast media | |
| Ioxaglate | Ioxaglate contrast media Receives: Other: contrast media |
What is being measured
The primary outcome is the main question the study is designed to answer.
Contrast-induced nephropathy incidence
Measured: Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization
Secondary outcomes (2)
Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization
Need for dialysis when patient develop end stage kidney failure -- by the time patient lose about 85 to 90 percent of your kidney function and have a glomerular filtration rate of <15.
Measured: 30 days
The individual components of the combined outcome (total mortality or dialysis indication)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2016
- Study completionNov 2020 (estimated)
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 Kidney FailureStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Dante Pazzanese de Cardiologia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RAFAELA ANDRADE PENALVA FREITAS, Instituto Dante Pazzanese de Cardiologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991742
- Sponsor's protocol ID
- 58593116.2.0000.5462
- Acronym
- IDPC
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 14 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Freitas RAP, Tanajura LF, Mehran R, Chamie D, Chaves A, Centemero M, Braga S, Costa R, Cao D, Sousa A, Feres F, Costa JR Jr. Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial. J Invasive Cardiol. 2023 Jun;35(6):E281-E290. doi: 10.25270/jic/21.00249. Epub 2023 May 16.
PubMed 37220640
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ioxaglate Versus Iodixanol for the Prevention of Contrast-induced Nephropathy in High-risk Patients After Diagnostic and Therapeutic Cardiac Catheterization (IDPC Trial)
- ClinicalTrials.gov ID
- NCT02991742
- Acronym / sponsor ID
- IDPC / 58593116.2.0000.5462
- Conditions
- Acute Kidney Failure
- Keywords
- nephropathy, catheterization, contrast media, ioxaglate, iodixanol, high risk, prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,262 participants (estimated)
- Lead sponsor
- Instituto Dante Pazzanese de CardiologiaUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Nov 2020 (estimated)
- First posted
- 13 Dec 2016 (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.
Contrast media-induced nephropathy following diagnostic and therapeutic cardiac catheterization.
Detailed description
Contrast-induced acute kidney injury represents a serious complication of procedures requiring administration of iodinated contrast media and is associated with the need for dialysis, prolonged hospitalization, increased costs, and mortality.
Contrast-induced nephropathy is defined as an increase of 25% in serum creatinine before the procedure.
Iodixanol, a nonionic, dimeric, iso-osmolar contrast medium may be less nephrotoxic than low-osmolar contrast media in high-risk patients.
The purpose of this study is to compare iodixanol versus ioxaglate in high risk patients between 48 and 96 hours after procedures that use contrast.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodixanol | – | Other: contrast mediaIodixanol contrast media |
| Ioxaglate | – | Other: contrast mediaIoxaglate contrast media |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary angiography or percutaneous interventions will be eligible for the trial if they have at least 1 risk factor for contrast-induced acute kidney injury
Key inclusion criteria (7 listed)
- At least one of the following criteria
- Aged more than 70 years-old
- Chronic renal failure
- Diabetes mellitus
- Congestive heart failure - left ventricular ejection fraction < 0.50
Key exclusion criteria (3 listed)
- Patients in dialysis
- Allergy to iodine
- Patient refusal to 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| contrast mediaAlso: Iodixanol X IoxaglateCompare 2 contrast media | Other | Iodixanol, Ioxaglate |
Primary outcome
Contrast-induced nephropathy incidence
Time frame: Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization
2 secondary outcomes
Composite of death or need for dialysis in 48 to 96 hours and at 30 days after diagnostic and therapeutic cardiac catheterization
Time frame: 30 days
The individual components of the combined outcome (total mortality or dialysis indication)
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2016.
- Derived from this study: PubMed 37220640Freitas RAP, Tanajura LF, Mehran R, Chamie D, Chaves A, Centemero M, Braga S, Costa R, Cao D, Sousa A, Feres F, Costa JR Jr. Ioxaglate Versus IoDixanol for the Prevention of Contrast-Induced Nephropathy: The IDPC Trial. J Invasive Cardiol. 2023 Jun;35(6):E281-E290. doi: 10.25270/jic/21.00249. Epub 2023 May 16.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Failure, run by Instituto Dante Pazzanese de Cardiologia.
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 7 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Contrast-induced nephropathy incidence (time frame: Between 48 and 96 hours after diagnostic and therapeutic cardiac catheterization). 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 NCT02991742, 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 14 Dec 2016.