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

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.

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 Overview

• Status: Completed
• Conditions: Nephropathy
• Intervention / Treatment: Other: Data extraction from medical files

• Study Type: Observational
• Enrollment (Actual): 3000

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1020
    • CHU Brugmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	7 years
Urea concentration	Urea concentration	Baseline (day of percutaneous coronary intervention (PCI))
Urea concentration	Urea concentration	24 hours after of PCI
Urea concentration	Urea concentration	48 hours after PCI
Urea concentration	Urea concentration	72 hours after PCI
Urea concentration	Urea concentration	21 days after PCI
Urea concentration	Urea concentration	1 year after PCI
Creatinin rate	Creatinin rate	Baseline (day of percutaneous coronary intervention (PCI))
Creatinin rate	Creatinin rate	24 hours after of PCI
Creatinin rate	Creatinin rate	48 hours after PCI
Creatinin rate	Creatinin rate	72 hours after PCI
Creatinin rate	Creatinin rate	21 days after PCI
Creatinin rate	Creatinin rate	1 year after PCI
Glomerular filtration rate	Glomerular filtration rate	Baseline (day of percutaneous coronary intervention (PCI))
Glomerular filtration rate	Glomerular filtration rate	24 hours after of PCI
Glomerular filtration rate	Glomerular filtration rate	48 hours after PCI
Glomerular filtration rate	Glomerular filtration rate	72 hours after PCI
Glomerular filtration rate	Glomerular filtration rate	21 days after PCI
Glomerular filtration rate	Glomerular filtration rate	1 year after PCI

Collaborators and Investigators

• Sponsor: Agnieszka Pozdzik
• Investigators: Principal Investigator: Sarah Bensliman, MD, CHU Brugmann

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): July 25, 2019
• Study Completion (ACTUAL): July 25, 2019

Study Registration Dates

• First Submitted: March 26, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (ACTUAL): April 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Kidney Diseases
• Other Study ID Numbers: CHUB-Bensliman

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No