Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment (PRECISE)
Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment: a Multicenter Randomized Controlled Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
A. Aged 18 to 80 years, inclusive, male or female; B. Diagnosed with acute kidney injury or chronic kidney disease stage 5, and assessed by a physician as requiring continuous renal replacement therapy (CRRT); C. Citrate metabolism disorder, including liver failure (acute liver failure, acute-on-chronic liver failure, or decompensated cirrhosis), and/or microcirculation disorder (mean arterial pressure <65 mmHg requiring vasopressor therapy and lactate ≥2 mmol/L); D. The investigator determines that the patient can have a stable vascular access established (the access must be capable of providing a constant and effective blood flow rate >150 ml/min); E. The study participant (subject) and their legal guardian are able to understand the study purpose and provide written informed consent.
Exclusion Criteria:
A. Received regional citrate anticoagulation therapy within the previous 72 hours; B. Expected to require additional non-protocol calcium supplementation during CRRT due to disease-related needs; C. Requiring arterial-venous reversal of the extracorporeal circuit during CRRT due to poor flow; D. Requiring concurrent peritoneal dialysis during the trial period; E. Participated in or is currently participating in another clinical trial within 1 month prior to the date of signing the informed consent form; F. Expected survival time less than 72 hours; G. Any other conditions that, in the investigator's judgment, make the patient unsuitable for participation in the clinical trial.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control
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The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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Experimental: Two-stage
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The two-stage calcium supplementation refers to: the first stage after the initiation of CRRT, the amount of calcium supplementation includes the calcium clearance from the extracorporeal circuit and the accumulated calcium citrate in the body; when the blood citrate concentration reaches a steady state, the second stage begins, at which point the accumulated calcium is stable and only the calcium clearance from the extracorporeal circuit needs to be supplemented.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intervention rate of iCa
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
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During the CRRT iCa is measured at pre-set time points.
If the iCa concentration is either <0.95 or >1.35 mmol/L in the body, or <0.25 or >0.4 mmol/L in the extracorporeal circuit, it is defined as "iCa requiring intervention".
If both intracorporeal and extracorporeal iCa require intervention at the same time point, it is counted as two interventions.
Finally, the intervention rate of iCa is calculated.
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From 1 hour post-CRRT initiation to the end of CRRT
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The filter failure rate and the causes of filter failure within 72 hours
Periodo de tiempo: The first 72 hours of CRRT
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The first 72 hours of CRRT
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The differences and proportional distributions of in vivo and in vitro iCa values at each time point between the two groups
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of bleeding events, the bleeding-related blood transfusions, and the total volume of transfused blood
Periodo de tiempo: From the initiation to the end of CRRT
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From the initiation to the end of CRRT
|
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The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of hypocalcemia and hypercalcemia
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
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The incidence of metabolic acidosis and metabolic alkalosis
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
|
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The incidence of hypernatremia
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
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From 1 hour post-CRRT initiation to the end of CRRT
|
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The incidence of clinically meaningful citrate accumulation
Periodo de tiempo: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
Colaboradores e Investigadores
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
- Enfermedades urogenitales
- Enfermedades urogenitales masculinas
- Enfermedades Renales
- Enfermedades urológicas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades del Sistema Digestivo
- Enfermedades del HIGADO
- Insuficiencia renal
- Insuficiencia hepática
- Lesión renal aguda
- Insuficiencia hepática
Otros números de identificación del estudio
- RCA-CRRT
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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