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

Само регистрирани потребители могат да превеждат статии

Вход / Регистрация

Линкът е запазен в клипборда

СъстояниеЗавършен

Спонсори

Agnieszka Pozdzik

КЛИНИЧНО ИЗСЛЕДВАНЕ: NCT03918824

BioSeek: nct03918824

Ключови думи

Резюме

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.

Дати

Последна проверка:	12/31/2019
Първо изпратено:	03/25/2019
Очаквано записване подадено:	04/15/2019
Първо публикувано:	04/17/2019
Изпратена последна актуализация:	01/23/2020
Последна актуализация публикувана:	01/26/2020
Действителна начална дата на проучването:	02/28/2019
Приблизителна дата на първично завършване:	07/24/2019
Очаквана дата на завършване на проучването:	07/24/2019

Състояние или заболяване

Nephropathy

Интервенция / лечение

Other: Data extraction from medical files

Фаза

Критерии за допустимост

Възрасти, отговарящи на условията за проучване	18 Years Да се 18 Years
Полове, допустими за проучване	All
Метод за вземане на проби	Non-Probability Sample
Приема здрави доброволци	Да
Критерии	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

Резултат

Първични изходни мерки

1. incidence of nephropathies induced by the injection of iodinate contrast medium [7 years]

incidence of nephropathy induced by injection of contrast medium

2. Volume of iodinated contrast medium injected [1 day]

Volume of iodinated contrast medium injected

3. Body mass [1 day]

Body mass

4. Urea concentration [10 days after PCI]

Urea concentration

5. Creatinin rate [10 days after PCI]

Creatinin rate

6. Glomerular filtration rate [10 days after PCI]

Glomerular filtration rate

Вторични изходни мерки

1. 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.

2. Urea concentration [Baseline (day of percutaneous coronary intervention (PCI))]

Urea concentration

3. Urea concentration [24 hours after of PCI]

Urea concentration

4. Urea concentration [48 hours after PCI]

Urea concentration

5. Urea concentration [72 hours after PCI]

Urea concentration

6. Urea concentration [21 days after PCI]

Urea concentration

7. Urea concentration [1 year after PCI]

Urea concentration

8. Creatinin rate [Baseline (day of percutaneous coronary intervention (PCI))]

Creatinin rate

9. Creatinin rate [24 hours after of PCI]

Creatinin rate

10. Creatinin rate [48 hours after PCI]

Creatinin rate

11. Creatinin rate [72 hours after PCI]

Creatinin rate

12. Creatinin rate [21 days after PCI]

Creatinin rate

13. Creatinin rate [1 year after PCI]

Creatinin rate

14. Glomerular filtration rate [Baseline (day of percutaneous coronary intervention (PCI))]

Glomerular filtration rate

15. Glomerular filtration rate [24 hours after of PCI]

Glomerular filtration rate

16. Glomerular filtration rate [48 hours after PCI]

Glomerular filtration rate

17. Glomerular filtration rate [72 hours after PCI]

Glomerular filtration rate

18. Glomerular filtration rate [21 days after PCI]

Glomerular filtration rate

19. Glomerular filtration rate [1 year after PCI]

Glomerular filtration rate

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

Ключови думи

хипоксия

захарен диабет

сърдечна недостатъчност

исхемична болест на сърцето

Резюме

Дати

Състояние или заболяване

Интервенция / лечение

Фаза

Критерии за допустимост

Резултат

Най-пълната база данни за лечебни билки, подкрепена от науката