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

NCT03918824 | Completed

• 1 other identifier: CHUB-Bensliman
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephropathy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (19)

• Existence of risk factors (yes/no)

  7 years

• Urea concentration

  Baseline (day of percutaneous coronary intervention (PCI))

• Urea concentration

  24 hours after of PCI

• Urea concentration

  48 hours after PCI

• Urea concentration

  72 hours after PCI

Interventions

Data extraction from medical files OTHER

Data extraction from medical files

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Agnieszka Pozdzik: lead

Study Sites (1)

CHU Brugmann

Brussels, 1020, Belgium

Location

MeSH Terms

Conditions

Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Sarah Bensliman, MD

  CHU Brugmann

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of nephro-dialysis clinic

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: April 18, 2019
• Study Start: March 1, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)