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Идёт набор NCT05339139

SAfety of Regional Citrate Anticoagulation (SARCA Study)

Фаза III С лечением Acute Kidney Injury ESRD

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dialysis.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury, ESRD. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

An Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO System in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study)

Обзор

This is an Open-label, Prospective, Multicenter Study to Assess the SAfety of Regional Citrate Anticoagulation Delivered by the multiFiltratePRO system in Adult Patients Requiring Continuous Renal Replacement Therapy (SARCA Study).

Подробное описание

In short, AKI is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need CRRT. The major advantage of CRRT is improved hemodynamic stability compared to intermittent HD. Continuous anticoagulation during CRRT may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. Unfractionated heparin is the most commonly used anticoagulation during CRRT mainly as a result of familiarity, low cost, and ease of administration. But the main drawback is the risk of bleeding.

An alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (RCA). The advantages of RCA are improved circuit patency and fewer bleeding complications. The use of RCA may also reduce the ICU staff workload. Studies have shown longer filter running times which reduced circuit change and set-up time. In addition, anticoagulation related bleeding, and CRRT-related blood transfusions were minimized. Therefore, CRRT with RCA might be more economical than conventional anticoagulation.

The study is to explore the possibility of using the multiFiltrate PRO system with the Ci-Ca module, Cifoban® (Trisodium citrate 4%), Calrecia® (Calcium chloride dihydrate), Ci-Ca dialysate K2 and K4, AV1000 (disposable cassette), and multiBic solution in subjects who are critically ill and receiving CRRT in an acute setting.

Вмешательства

  • Комбинированный продукт Dialysis
    In this study critically ill adult patients requiring Continuous Renal Replacement Therapy (CRRT) will receive Regional Citrate Anticoagulation (CRA) which will be delivered by multiFiltratePRO system.

Первичные конечные точки

  • Symptoms and systemic ionized calcium level [Срок оценки: Up to 1 month]
  • Arterial pH measure and bicarbonate level [Срок оценки: Up to 1 month]
  • Serum sodium (Na) level [Срок оценки: Up to 1 month]
  • Drop in hemoglobin (Hgb) [Срок оценки: Up to 1 month]
  • Symptoms and systemic ionized calcium level [Срок оценки: Up to 1 month]
  • Symptoms and total-to-ionized calcium ratio [Срок оценки: Up to 1 month]
Вторичные конечные точки (1)
  • Circuit life [Срок оценки: The life of a circuit is 72 hrs and then it needs to be replaced . Subject participation is upto 1 month.]

Критерии участия

Критерии включения

  • Signed informed consent form by
  • The subject or
  • A legally authorized representative (LAR), if the subject is unable to consent
  • Adult patients ≥ 18 years old
  • Diagnosis of AKI or End-Stage Kidney Disease (ESKD) requiring CRRT
  • Vascular access - Dialysis Catheter with size and location per institutional practice

Критерии исключения

  • Metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/L and arterial pH greater than 7.55
  • A female who is pregnant or breast feeding
  • Severe liver disease defined as International Normalized Ratio (INR) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (AST) and alanine aminotransferase (ALT) greater than 3 times upper limit of normal
  • Subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent
  • Previous participation in a similar or the same study.
  • Subjects already on continuous renal replacement therapy
  • Subjects with active COVID-19 infection
  • Subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

США · 10 центров
  • John L. McClellan Memorial Veterans' Hospital — Little Rock
  • University of Arkansas for Medical Sciences (UAMS) — Little Rock
  • Advent Health Orlando — Orlando
  • UMass Memorial Medical Center — Worcester
  • University of Michigan — Ann Arbor
  • Henry Ford Hospital — Detroit
  • Mayo Clinic — Rochester
  • University of Mississippi Medical Center — Jackson
  • … и ещё 2 центра

Идентификаторы

NCT: NCT05339139 · Ci-Ca-001

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗