Influence of Iodinated Contrast Volume Injected During Coronarography on Contrast Nephropathy.

Completed

• Conditions: Nephropathy

• Registration Number: NCT03918824
• Lead Sponsor: Agnieszka Pozdzik

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-03-01
• Study First Submitted: 2019-03-26
• Study First Submitted QC: 2019-04-16
• Study First Posted: 2019-04-18
• Primary Completion: 2019-07-25
• Study Completion: 2019-07-25
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• 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

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volume of iodinated contrast medium injected	1 day	Volume of iodinated contrast medium injected
Body mass	1 day	Body mass
Urea concentration	10 days after PCI	Urea concentration
Creatinin rate	10 days after PCI	Creatinin rate
Glomerular filtration rate	10 days after PCI	Glomerular filtration rate
incidence of nephropathies induced by the injection of iodinate contrast medium	7 years	incidence of nephropathy induced by injection of contrast medium

Secondary Outcome Measures

Name	Time	Method
Urea concentration	1 year after PCI	Urea concentration
Creatinin rate	1 year after PCI	Creatinin rate
Existence of risk factors (yes/no)	7 years	Existence of at least one of these risk factors: diabetes mellitus, abnormal blood pressure, abnormal kidney function, congestive heart failure.
Glomerular filtration rate	1 year after PCI	Glomerular filtration rate

Trial Locations

Locations (1)

CHU Brugmann; 🇧🇪 Brussels, Belgium