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
Aperçu de l'étude
Statut
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Contrôler
|
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Intervention rate of iCa
Délai: From 1 hour post-CRRT initiation to the end of CRRT
|
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.
|
From 1 hour post-CRRT initiation to the end of CRRT
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
The filter failure rate and the causes of filter failure within 72 hours
Délai: The first 72 hours of CRRT
|
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
Délai: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of bleeding events, the bleeding-related blood transfusions, and the total volume of transfused blood
Délai: From the initiation to the end of CRRT
|
From the initiation to the end of CRRT
|
|
The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
Délai: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of hypocalcemia and hypercalcemia
Délai: 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 metabolic acidosis and metabolic alkalosis
Délai: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of hypernatremia
Délai: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
|
The incidence of clinically meaningful citrate accumulation
Délai: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
Collaborateurs et enquêteurs
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
Termes MeSH pertinents supplémentaires
- Maladies urogénitales
- Maladies urogénitales masculines
- Maladies rénales
- Maladies urologiques
- Maladies urogénitales féminines
- Maladies urogénitales féminines et complications de la grossesse
- Maladies du système digestif
- Maladies du foie
- Insuffisance rénale
- Insuffisance hépatique
- Lésion rénale aiguë
- Insuffisance hépatique
Autres numéros d'identification d'étude
- RCA-CRRT
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
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