- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07679568
Analysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation (RCA-Flux)
Analysis of CKRT Treatments With multiFlux Hemofilters Using RCA or Systemic Heparin Anticoagulation
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Dispositif: multiFlux 160 hemofilter with regional heparin anticoagulation
- Dispositif: multiFlux 160 hemofilter with RCA with regional citrate anticoagulation
- Dispositif: multiFlux 130 hemofilter with regional heparin anticoagulation
- Dispositif: multiFlux 130 hemofilter with RCA with regional citrate anticoagulation
- Dispositif: multiFlux 60 hemofilter with regional heparin anticoagulation
- Dispositif: multiFlux 60 hemofilter with RCA with regional citrate anticoagulation
Description détaillée
Patients enrolled in this clinical investigation will be treated either with citrate anticoagulation in Continuous venovenous hemodialysis (CVVHD) or Continuous venovenous hemodiafiltration (CVVHDF) in post-dilution mode (RCA-post-CVVHDF) with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier)) or with heparin in any of the possible CKRT modes (pre-, post- or pre-post CVVH, CVVHD, pre-, post- or pre-post CVVHDF) for up to 10 days based on investigator´s decision (data beyond 10 days will not be collected within the study) or until withdrawal of informed consent or death.
For the study, treatment data will be documented for a maximum of 10 days.
The selection of the filter size depends on the prescription of the attending physician. The body weight limitations as shall be considered:
Mutiflux 160 ≥ 40 kg, Multiflux 130 ≥ 30 kg, Multiflux 60 ≥ 8 kg
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Anja Derlet-Savoia, Dr.
- Numéro de téléphone: +49 6172 268 6648
- E-mail: Anja.Derlet@freseniusmedicalcare.com
Sauvegarde des contacts de l'étude
- Nom: Celina Meyer
- Numéro de téléphone: +49 6172 268 6809
- E-mail: celina.meyer@freseniusmedicalcare.com
Lieux d'étude
-
-
Bavaria
-
Munich, Bavaria, Allemagne, 81377
- Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
-
Contact:
- Christina Christina Scharf-Janßen, Dr. med.
- Numéro de téléphone: 089-4400-84163
- E-mail: christina.scharf-janssen@med.uni-muenchen.de
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
General:
Patients ≥ 18 years:
Informed consent signed and dated by the investigator; and
- if patient is able to give consent: by the study patient
- if patients unable to give consent: by the legal representative/spouse according to § 1358 BGB or
if an emergency situation is determined: by an independent consultant physician.
Pediatric Patients < 18 years:
- Informed consent signed and dated by legal representative and investigator/ authorized physician.
- The minors have received the information referred to in Article 63(2) Medical Device Regulation (MDR) in a way adapted to their age and mental maturity and from investigators or members of the investigating team who are trained or experienced in working with children. If able, the minors have to sign the informed consent, too.
- The explicit wish of a minor who is capable of forming an opinion and assessing the information referred to in Article 63(2) MDR to refuse participation in, or to withdraw from, the clinical investigation at any time, is respected by the investigator
Study specific:
- Body weight ≥ 8kg
- Acute Kidney Injury (AKI) with clinical indication for CKRT
- Clinically estimated life expectancy greater than 3 days
Exclusion Criteria:
- Any conditions which could interfere with the patient's ability to comply with the study
- Patient or legal representative or authorized physician during emergency situation is not able to give informed consent according to European Medical Device Regulation and corresponding national regulations
- Participation in a different interventional clinical study during the preceding 30 days
- Previous participation in the same study
- Uncontrolled bleeding and coagulation disorders
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
AKI patients
Patients with acute Kidney Injury (AKI) with clinical indication for CKRT
|
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 160 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 130 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux130 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA systemic heparin anticoagulation for patients suffering from acute kidney injury (AKI)
Extracorporeal blood purification with the multiFlux 60 hemofilter during continuous kidney replacement therapy with RCA using 4% citrate with Ci-Ca dialysate (without gas barrier) for patients suffering from acute kidney injury (AKI)
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
Délai: From enrollment up to 10 days
|
From enrollment up to 10 days
|
|
Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
Délai: From enrollment up to 10 days
|
From enrollment up to 10 days
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Christina Scharf-Janßen, PD Dr. med., LMU University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CKRT-AKI-04-EU
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .