NephropathyNCT03918824
Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.
An observational study of Nephropathy, run by Agnieszka Pozdzik at 1 site in Belgium.
Trial summary
Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephropathy
- What is being tested?
- Data extraction from medical files
- How many people
- 3,000 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2019to 25 Jul 2019
- 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: All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013.
Who may be able to join
- All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013
- Access to extensive demographic, clinical and biological data
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of the Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.
Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the treatment.
For the vast majority of the population, exposure to ICP is perfectly well tolerated. Nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (NIC). NIC is the third cause of an acquired acute renal failure within the hospital.It significantly increases morbidity and mortality and prolongs the hospital stay.
Read more
Of all the procedures requiring ICP administration, PCI is associated with the highest rate of NIC.This evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.Age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing NIC.
Nowadays, the use of PCI in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. This is linked to the aging of the population and the increasing incidence of cardiovascular diseases.
ICP-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.These intra-renal mechanisms lead to an acute renal function impairment.NIC is defined as an increase of serum creatinemia ≥ 0.5 mg / dL (or a 25% increase) from the baseline in the 48-72h following PC injection with no other obvious etiology. It reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days.
The prevention of NIC based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). In contrast, there is little data on the relationship between NIC and the PCI volume used. To the investigator's knowledge, the threshold of toxic volume is not well defined. Taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an ICP and the occurrence of a NIC according to the criteria mentioned above.
- Conditions
- Nephropathy
- Being tested
- Data extraction from medical files
- Medical subject headings
- Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data extraction from medical filesOther
Data extraction from medical files
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of nephropathies induced by the injection of iodinate contrast medium
incidence of nephropathy induced by injection of contrast medium
Measured: 7 years
Volume of iodinated contrast medium injected
Volume of iodinated contrast medium injected
Measured: 1 day
Body mass
Body mass
Measured: 1 day
Urea concentration
Urea concentration
Measured: 10 days after PCI
Creatinin rate
Creatinin rate
Measured: 10 days after PCI
Glomerular filtration rate
Glomerular filtration rate
Measured: 10 days after PCI
Secondary outcomes (19)
Existence of risk factors (yes/no)
Existence of at least one of these risk factors: diabetes mellitus, abnormal blood pressure, abnormal kidney function, congestive heart failure.
Measured: 7 years
Urea concentration
Urea concentration
Measured: Baseline (day of percutaneous coronary intervention (PCI))
Urea concentration
Urea concentration
Measured: 24 hours after of PCI
Urea concentration
Urea concentration
Measured: 48 hours after PCI
Urea concentration
Urea concentration
Measured: 72 hours after PCI
Urea concentration
Urea concentration
Measured: 21 days after PCI
Urea concentration
Urea concentration
Measured: 1 year after PCI
Creatinin rate
Creatinin rate
Measured: Baseline (day of percutaneous coronary intervention (PCI))
Creatinin rate
Creatinin rate
Measured: 24 hours after of PCI
Creatinin rate
Creatinin rate
Measured: 48 hours after PCI
Creatinin rate
Creatinin rate
Measured: 72 hours after PCI
Creatinin rate
Creatinin rate
Measured: 21 days after PCI
Creatinin rate
Creatinin rate
Measured: 1 year after PCI
Glomerular filtration rate
Glomerular filtration rate
Measured: Baseline (day of percutaneous coronary intervention (PCI))
Glomerular filtration rate
Glomerular filtration rate
Measured: 24 hours after of PCI
Glomerular filtration rate
Glomerular filtration rate
Measured: 48 hours after PCI
Glomerular filtration rate
Glomerular filtration rate
Measured: 72 hours after PCI
Glomerular filtration rate
Glomerular filtration rate
Measured: 21 days after PCI
Glomerular filtration rate
Glomerular filtration rate
Measured: 1 year after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2019
- Study start1 Mar 2019
- Primary completion25 Jul 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephropathyStudies 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
- Retrospective
- Enrolment
- 3,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agnieszka Pozdzik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Agnieszka Pozdzik, Brugmann University Hospital
- Investigators
- Sarah Bensliman, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03918824
- Sponsor's protocol ID
- CHUB-Bensliman
- Status last verified
- Jan 2020
- First submitted
- 26 Mar 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of the Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.
- ClinicalTrials.gov ID
- NCT03918824
- Acronym / sponsor ID
- CHUB-Bensliman
- Conditions
- Nephropathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (actual)
- Lead sponsor
- Agnieszka PozdzikUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 25 Jul 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 18 Apr 2019 (actual)
- 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.
Coronary heart disease remains one of the main causes of death in the world. One of the treatments for coronary heart disease is percutaneous coronary intervention (PCI). This requires the arterial administration of iodinated contrast medium (ICP) to visualize the state of the coronary arteries and possibly apply the treatment.
For the vast majority of the population, exposure to ICP is perfectly well tolerated. Nevertheless, some complications can occur including a nephropathy induced by the injection of a contrast product (NIC). NIC is the third cause of an acquired acute renal failure within the hospital.It significantly increases morbidity and mortality and prolongs the hospital stay.
Of all the procedures requiring ICP administration, PCI is associated with the highest rate of NIC.This evidence is explained by the fact that patients benefiting from such exploration have a higher risk profile in terms of cardiovascular comorbidities and associated pathologies.Age, preexisting alteration of renal function, diabetes mellitus, polypharmacy, congestive heart failure, type and volume of iodinated contrast medium are the main risk factors for developing NIC.
Nowadays, the use of PCI in the assessment of coronary heart disease in patients with these risk factors is becoming more frequent. This is linked to the aging of the population and the increasing incidence of cardiovascular diseases.
ICP-induced nephrotoxicity results from two main phenomena: the renal medullary hypoxia caused by the vasoconstriction of peritubular capillaries and a direct cytotoxicity towards tubular epithelial cells.These intra-renal mechanisms lead to an acute renal function impairment.NIC is defined as an increase of serum creatinemia ≥ 0.5 mg / dL (or a 25% increase) from the baseline in the 48-72h following PC injection with no other obvious etiology. It reaches its peak between the 3rd and 5th day with a resolution in 10 to 21 days.
The prevention of NIC based primarily on the identification of patients at risk and the use of pharmacological means (as hydration protocol). In contrast, there is little data on the relationship between NIC and the PCI volume used. To the investigator's knowledge, the threshold of toxic volume is not well defined. Taking into account these elements, the investigators propose to study the relation between the volume of iodinated contrast product injected during an ICP and the occurrence of a NIC according to the criteria mentioned above.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013.
Key inclusion criteria (2 listed)
- All adult patients who have undergone percutaneous coronary intervention with contrast medium Xenetic (Lobitridol ®) in the CHU Brugmann Hospital coronary angiography unit since 2013
- Access to extensive demographic, clinical and biological data
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Data extraction from medical filesData extraction from medical files | Other | – |
Primary outcome
incidence of nephropathies induced by the injection of iodinate contrast medium
Time frame: 7 years
incidence of nephropathy induced by injection of contrast medium
Volume of iodinated contrast medium injected
Time frame: 1 day
Volume of iodinated contrast medium injected
Body mass
Time frame: 1 day
Body mass
Urea concentration
Time frame: 10 days after PCI
Urea concentration
Creatinin rate
Time frame: 10 days after PCI
Creatinin rate
Glomerular filtration rate
Time frame: 10 days after PCI
Glomerular filtration rate
19 secondary outcomes
Existence of risk factors (yes/no)
Time frame: 7 years
Urea concentration
Time frame: Baseline (day of percutaneous coronary intervention (PCI))
Urea concentration
Time frame: 24 hours after of PCI
Urea concentration
Time frame: 48 hours after PCI
Urea concentration
Time frame: 72 hours after PCI
Urea concentration
Time frame: 21 days after PCI
Urea concentration
Time frame: 1 year after PCI
Creatinin rate
Time frame: Baseline (day of percutaneous coronary intervention (PCI))
Creatinin rate
Time frame: 24 hours after of PCI
Creatinin rate
Time frame: 48 hours after PCI
Creatinin rate
Time frame: 72 hours after PCI
Creatinin rate
Time frame: 21 days after PCI
Creatinin rate
Time frame: 1 year after PCI
Glomerular filtration rate
Time frame: Baseline (day of percutaneous coronary intervention (PCI))
Glomerular filtration rate
Time frame: 24 hours after of PCI
Glomerular filtration rate
Time frame: 48 hours after PCI
Glomerular filtration rate
Time frame: 72 hours after PCI
Glomerular filtration rate
Time frame: 21 days after PCI
Glomerular filtration rate
Time frame: 1 year after PCI
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 27 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Sarah Bensliman, MD principal investigator
CHU Brugmann
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 Nephropathy, run by Agnieszka Pozdzik at 1 site in Belgium.
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 2 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 27 Jan 2020. 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 Belgium. 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?
incidence of nephropathies induced by the injection of iodinate contrast medium (time frame: 7 years). The study lists 6 primary outcomes in all. 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 27 Jan 2020.