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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: Kontrollera
|
The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.
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Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intervention rate of iCa
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The filter failure rate and the causes of filter failure within 72 hours
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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 metabolic acidosis and metabolic alkalosis
Tidsram: 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
Tidsram: 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
Tidsram: From 1 hour post-CRRT initiation to the end of CRRT
|
From 1 hour post-CRRT initiation to the end of CRRT
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RCA-CRRT
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