- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Dispositivo: multiFlux 160 hemofilter with regional heparin anticoagulation
- Dispositivo: multiFlux 160 hemofilter with RCA with regional citrate anticoagulation
- Dispositivo: multiFlux 130 hemofilter with regional heparin anticoagulation
- Dispositivo: multiFlux 130 hemofilter with RCA with regional citrate anticoagulation
- Dispositivo: multiFlux 60 hemofilter with regional heparin anticoagulation
- Dispositivo: multiFlux 60 hemofilter with RCA with regional citrate anticoagulation
Descripción detallada
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
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Anja Derlet-Savoia, Dr.
- Número de teléfono: +49 6172 268 6648
- Correo electrónico: Anja.Derlet@freseniusmedicalcare.com
Copia de seguridad de contactos de estudio
- Nombre: Celina Meyer
- Número de teléfono: +49 6172 268 6809
- Correo electrónico: celina.meyer@freseniusmedicalcare.com
Ubicaciones de estudio
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Bavaria
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Munich, Bavaria, Alemania, 81377
- Klinikum der Ludwig-Maximilians-Universität München (LMU Klinikum)
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Contacto:
- Christina Christina Scharf-Janßen, Dr. med.
- Número de teléfono: 089-4400-84163
- Correo electrónico: christina.scharf-janssen@med.uni-muenchen.de
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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)
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Rate of clearance (Creatinine reduction in blood and effluent) as therapy efficacy at specified time points
Periodo de tiempo: From enrollment up to 10 days
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From enrollment up to 10 days
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Assessment of potential electrolyte imbalances or acid base disturbances during RCA treatment
Periodo de tiempo: From enrollment up to 10 days
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From enrollment up to 10 days
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Christina Scharf-Janßen, PD Dr. med., LMU University Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CKRT-AKI-04-EU
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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