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Идёт набор NCT06799910

Optimization of Fluid Balance Guided by Bioelectrical Impedance Analysis in Patients Undergoing Continuous Renal Replacement Therapy in Critical Care

Без фазы С лечением Congestion RRT UF Bio-impendance Analysis

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: continuous renal replacement therapy (CRRT), Free UF Prescription.
Кому может быть актуально
Состояния в реестре: Congestion, RRT, UF, Bio-impendance Analysis. 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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Обзор

In critical care, hemodynamic instability often requires volume expansion to restore tissue perfusion, increasing fluid balance and TBW, factors associated with higher mortality. Excess fluid leads to organ dysfunction due to venous congestion, making fluid removal crucial. When diuretics fail, RRT, typically through continuous renal replacement therapy (CRRT), is recommended. However, prescribing the correct level of UF is challenging; insufficient UF can worsen edema, while excessive UF risks hemodynamic instability. This pilot, single-center, prospective, interventional, randomized, controlled, open-label study includes two parallel groups: a standard group with UF prescribed by the physician based on clinical and hemodynamic status and an experimental group with UF guided by the extracellular to total body water (ECW/TBWat) ratio measured by BIA. The aim is to determine if ECW/TBW-guided UF improves fluid and TBW reduction over a 72-hour RRT period.

Вмешательства

  • Процедура continuous renal replacement therapy (CRRT)
    The patient is included in the study once they meet the eligibility criteria and as soon as the responsible physician has prescribed RRT according to the department's protocol. Randomization will be performed, and the patient will be assigned to either the standard or experimental groups.
  • Другое Free UF Prescription
    The UF (ml/h) is prescribed by the responsible physician based on the patient's clinical, congestive, and hemodynamic status. The physician can implement the UF whenever necessary based on the patient's hemodynamic condition.

Первичные конечные точки

  • comparison of TBW between both groups [Срок оценки: at 72 hours]
Вторичные конечные точки (12)
  • Variation of cumulative net UF [Срок оценки: at 72 hours]
  • Measurement of the net UF rate [Срок оценки: at 72 hours]
  • Measurement of the ECW/TBWATratio and its association with the VeXUS score [Срок оценки: day 0]
  • Measurement of the ECW/TBWATratio and its association with the VeXUS score [Срок оценки: at 72 hours]
  • Measurement of the ECW/TBWAT ratio [Срок оценки: day 0]
  • Measurement of the ECW/TBWAT ratio [Срок оценки: 72 hours]
  • number of filters used in both groups [Срок оценки: at 24 hours]
  • number of filters used in both groups [Срок оценки: at 48 hours]
  • number of filters used in both groups [Срок оценки: at 72 hours]
  • duration of use for each filter in both groups [Срок оценки: at 24 hours]
  • duration of use for each filter in both groups [Срок оценки: at 48 hours]
  • duration of use for each filter in both groups [Срок оценки: at 72 hours]

Критерии участия

Критерии включения

  • Age > 18 years
  • The patient was hospitalized in the intensive care unit of Amiens-Picardie University Hospital.
  • Patient with an increase in fluid balance (TBW > 5%)
  • Patient receiving continuous veno-venous hemofiltration (CVVH) on a PrismaFlexR or PrisMaxR machine, initiated due to oliguria, potassium level > 6.5 mmol/L, urea level > 25 mmol/L, or creatinine > 300 µmol/L and severe metabolic acidosis (pH < 7.2).
  • Hemodynamically stable patient with a mean arterial pressure (MAP) > 65 mmHg for more than 4 hours with norepinephrine.
  • Signed consent to participate in the study by the patient or, if unconscious, their legal representative/next of kin.

Критерии исключения

  • Invalid BIA measurements
  • Internal device powered by an electrical current (pacemaker, implantable cardioverter-defibrillator, neurostimulator)
  • Cardiac arrhythmia (atrial fibrillation, atrial flutter) present at the inclusion
  • Chronic dialysis patient
  • Moribund patient
  • The patient is on extracorporeal mechanical support
  • Hemorrhagic shock
  • Pregnant woman
  • Patient under guardianship or conservators.

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
Открытое
Основная цель
Другое

Центры проведения

Франция · 1 центр
  • CHRU Amiens — Salouël

Идентификаторы

NCT: NCT06799910 · PI2022_843_0069

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗