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Not yet recruiting NCT07579663

Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment

No phase Interventional AKI - Acute Kidney Injury CKD 5D, Hemodialysis Hepatic Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Two-stage calcium supplementation in RCA-CRRT, Commercial RCA-CRRT module.
Who it may be relevant to
Registry conditions: AKI - Acute Kidney Injury, CKD 5D, Hemodialysis, Hepatic Failure. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Personalized Two-stage Regional Citrate Anticoagulation for CRRT in Patients With Citrate Metabolism Impairment: a Multicenter Randomized Controlled Study

Overview

The purpose of this study is to compare the efficacy and safety of an individualized two-stage calcium supplementation method versus a conventional commercial RCA-CRRT module in RCA-CRRT for patients with citrate metabolism disorders.

Interventions

  • Other Two-stage calcium supplementation in RCA-CRRT
    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.
  • Other Commercial RCA-CRRT module
    The recommended supplementation method for citrate and calcium agents in the CRRT citrate module by Fresenius Medical Care.

Primary outcome measures

  • Intervention rate of iCa [Time frame: From 1 hour post-CRRT initiation to the end of CRRT]
Secondary outcome measures (8)
  • The filter failure rate and the causes of filter failure within 72 hours [Time frame: The first 72 hours of CRRT]
  • The differences and proportional distributions of in vivo and in vitro iCa values at each time point between the two groups [Time frame: 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 [Time frame: From the initiation to the end of CRRT]
  • The incidence of arrhythmias and neurological symptoms caused by abnormal iCa [Time frame: From 1 hour post-CRRT initiation to the end of CRRT]
  • The incidence of hypocalcemia and hypercalcemia [Time frame: From 1 hour post-CRRT initiation to the end of CRRT]
  • The incidence of metabolic acidosis and metabolic alkalosis [Time frame: From 1 hour post-CRRT initiation to the end of CRRT]
  • The incidence of hypernatremia [Time frame: From 1 hour post-CRRT initiation to the end of CRRT]
  • The incidence of clinically meaningful citrate accumulation [Time frame: From 1 hour post-CRRT initiation to the end of CRRT]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07579663 · RCA-CRRT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗