Blood-Brain Barrier Evaluation In Nephrology (BREIN)
Mots clés
Abstrait
Rendez-vous
Dernière vérification: | 02/29/2020 |
Première soumission: | 03/27/2020 |
Inscription estimée soumise: | 03/27/2020 |
Première publication: | 03/30/2020 |
Dernière mise à jour soumise: | 03/27/2020 |
Dernière mise à jour publiée: | 03/30/2020 |
Date de début réelle de l'étude: | 05/31/2020 |
Date d'achèvement primaire estimée: | 01/06/2022 |
Date estimée d'achèvement de l'étude: | 06/06/2022 |
Condition ou maladie
Intervention / traitement
Radiation: Cerebral scintigraphy
Phase
Groupes d'armes
Bras | Intervention / traitement |
---|---|
Experimental: healthy volunteers | |
Experimental: patients with Chronic Kidney Disease |
Critère d'éligibilité
Âges éligibles aux études | 18 Years À 18 Years |
Sexes éligibles à l'étude | All |
Accepte les bénévoles en santé | Oui |
Critères | Inclusion Criteria: - Patients : - over 18 years old - social security recipients - in chronic hemodialysis at least 3 times 4 hours a week for at least 3 months - having a negative pregnancy test less than 2 weeks old for women of childbearing age - who have given informed consent to participate in the study - Healthy controls, matched in age (+/- 5 years) and sex to a patient : - over 18 years old - social security recipients - having a negative pregnancy test less than 2 weeks old for women of childbearing age - who have given informed consent to participate in the study Exclusion Criteria: - • Patients and healthy controls : - Pregnant or breastfeeding women, a negative pregnancy test less than 2 weeks old will be required prior to inclusion for women of childbearing age. - Majors under legal protection - Lack of affiliation to a social security scheme - Inability to give informed consent - Persons deprived of liberty - Date of last menstrual period > 1 month in the absence of effective contraception in patients of childbearing age with a conserved menstrual cycle - Known neurodegenerative disease - Major Cardiovascular Disease : Unbalanced hypertension (defined as systolic blood pressure > 160 mmHg), history of stroke or coronary artery disease. - Ongoing neoplastic or infectious disease - Taking non-steroidal anti-inflammatory drugs within 48 hours before inclusion - Ongoing drug treatment that may induce attention and/or cognitive deficits (anticholinergics, sedatives, neuroleptics) - Known hypersensitivity to the radiotracer or a component of it • Patients : - Non-compliance with dialysis sessions |
Résultat
Mesures des résultats primaires
1. Ratio of intracerebral activity of 99mTc-DTPA (marker of BBB rupture) to total injected activity [1 day]