Comparison of RCA and RACD in Extra-renal Purification by SLED
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: Sustained Low-Efficiency Dialysis.
- Кому может быть актуально
- Состояния в реестре: Acute Kidney Injury. 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
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Comparison of Regional Citrate Anticoagulation (RCA) and Regional Anticoagulation by Citrate-Free Decalcification in Renal (RACD) Replacement Therapy Using Sustained Low-Efficiency Dialysis
Обзор
One of the main RRT issues is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate Anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol / L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic flow of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aim to compare intermittent RRT using 4% Citrate infusion and without Citrate.
Подробное описание
Background: Renal Replacement Therapy (RRT), requires anticoagulation of the extracorporal circuit (ECC) using heparin, citrate or repeated rinsing. Difficulties of implementation or exposition to complications (thrombosis, hemorrhage or electrolyte disorder) are frequent.
Purpose: Regional anticoagulation of the ECC based on ionized calcemia reduction, as using citrate, but induced by the use of a calcium-free dialysate associated with the performance of the hemofilter could reduce these risks and the cost of intermittent RRT. This study aims to compare the efficiency of a regional anticoagulation technique based on the reduction of Ionized Calcium in the extracorporal circuit, without the use of Citrate and with Citrate during intermittent RRT.
Abstract: One of the main RRT issue is anticoagulation of the ECC, because blood contact with biomaterials causes bio-incompatibility reactions, including activation of the coagulation cascade. Based on Regional Citrate anticoagulation (RCA) protocols, an ionized calcium (Ca-ion) concentration around 0.25 to 0.35mmol/L prevents fibrino formation and allows anticoagulation for the ECC. During RCA, metabolic side effects may occur due to systemic passage of citrate. Our postulate is that reduction of ionized calcemia related to the use of a calcium-free dialysate and haemofilter performance makes it possible to avoid citrate infusion. Our study aims at comparing intermittent RRT using 4% Citrate infusion and without Citrate.
Вмешательства
- Процедура Sustained Low-Efficiency Dialysis
All patient requiring Renal replacement Therapy in the intensive care unit will be randomized in open order (cross-over) with either Regional anticoagulation with Citrate or Regional anticoagulation by Decalcification without Citrate
Первичные конечные точки
- Measurement of the plasma urea [Срок оценки: up to 8 hours]
Вторичные конечные точки (7)
- Measurement of the concentration of Ca²+i in post-filter [Срок оценки: 30 minutes, 1 hour; 4 hours and 8 hours]
- Measurement of the concentration of Ca²+i (patient) [Срок оценки: 30minutes, 1 hour; 4 hours and 8 hours]
- Measurement of the concentration of Mg2+ [Срок оценки: 8 hours]
- Measurement of heart rate during each RRT session. [Срок оценки: Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes]
- Measurement of blood pressure [Срок оценки: Hour 0; 30 minutes; 60 minutes; 90 minutes; 120 minutes; 150 minutes; 180 minutes; 210 minutes; 240 minutes; 270 minutes; 300 minutes; 330 minutes; 360 minutes; 390 minutes; 420 minutes; 450 minutes; 480 minutes]
- Number of circuit losses during each RRT session, [Срок оценки: Hour 0; 480 minutes]
- Number of catheter thrombosis during each RRT session [Срок оценки: Hour 0; 480 minutes]
Критерии участия
Критерии включения
- All patient requiring Renal replacement Therapy
Критерии исключения
- Age < 18 years
- Pregnancy
- Hypercalcemia ≥ 3 mmol/L.
- Major under guardianship
- Major deprived of freedom
- Impossible to obtain free and informed consent
- Presence of hemostasis or coagulation disorders:
- Thrombocytopenia < 30 G/L.
- Curative anticoagulation.
- Severe liver disease with Prothrombin rate <30%.
- Coagulation factor deficit.
- Not registered to a social security system.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
Франция · 1 центр
- Groupe Hospitalier Sud Ile-de-France — Melun
Идентификаторы
NCT: NCT04968587 · 2020-A0122-37