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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Intervention rate of iCa [Срок оценки: From 1 hour post-CRRT initiation to the end of CRRT]

Вторичные конечные точки (8)

• The filter failure rate and the causes of filter failure within 72 hours [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From the initiation to the end of CRRT]
• The incidence of arrhythmias and neurological symptoms caused by abnormal iCa [Срок оценки: From 1 hour post-CRRT initiation to the end of CRRT]
• The incidence of hypocalcemia and hypercalcemia [Срок оценки: From 1 hour post-CRRT initiation to the end of CRRT]
• The incidence of metabolic acidosis and metabolic alkalosis [Срок оценки: From 1 hour post-CRRT initiation to the end of CRRT]
• The incidence of hypernatremia [Срок оценки: From 1 hour post-CRRT initiation to the end of CRRT]
• The incidence of clinically meaningful citrate accumulation [Срок оценки: From 1 hour post-CRRT initiation to the end of CRRT]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07579663 · RCA-CRRT

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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