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
Panoramica dello studio
Stato
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: Controllo
|
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intervention rate of iCa
Lasso di tempo: 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.
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From 1 hour post-CRRT initiation to the end of CRRT
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
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The filter failure rate and the causes of filter failure within 72 hours
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From the initiation to the end of CRRT
|
From the initiation to the end of CRRT
|
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The incidence of arrhythmias and neurological symptoms caused by abnormal iCa
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie urogenitali maschili
- Malattie renali
- Malattie urologiche
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie dell'apparato digerente
- Malattie del fegato
- Insufficienza renale
- Insufficienza epatica
- Danno renale acuto
- Insufficienza epatica
Altri numeri di identificazione dello studio
- RCA-CRRT
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
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