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Идёт набор NCT07293936

Post-Filter Hematocrit

Без фазы С лечением Continuous Renal Replacement Therapy Renal Failure Hemofilter Clotting

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: Calculated Post-Filter Hematocrit, Measured Post-Filter Hematocrit.
Кому может быть актуально
Состояния в реестре: Continuous Renal Replacement Therapy, Renal Failure, Hemofilter Clotting. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Validation of a Post-Filter Hematocrit Calculation Formula: A Comparative Analysis With Measured Post-Filter Hematocrit Values

Обзор

Filter clotting is a major complication of continuous renal replacement therapy (CRRT), resulting in blood loss, reduced treatment efficacy, and increased cost. One modifiable factor associated with filter clotting is filtration fraction (FF), or the proportion of plasma water being removed from the blood over the course of the filter. In convention, a cutoff of FF\<20-30% has been used to prevent hemofilter clotting, but no evidence correlating FF with hemofilter clotting has been documented. Some experts have proposed that post-filter hematocrit (Hct) could be a more direct marker for determining hemofilter clotting risk, but evidence supporting clinical utility of this marker is lacking. HCTpost=HCTpre/(FF(HCTpre-1)+1) In our proposed validation study, we hope to determine whether our formula for post-filter Hct provides accurate results when compared to measured values. The information obtained from this study will potentially justify the use of utilizing the formula in future studies. The procedure of this study is collecting blood samples from the post-filter lines of patients on CRRT at different time points and different flow rates. This will be considered the "measured post-filter hematocrit" which will then be compared to the calculated formula above, using the other values obtained from daily labs (for pre-filter hematocrit) and CRRT machine settings.

Подробное описание

This investigational study is listed as "other" because it is a validation study comparing two measurement methods-comparing a calculated versus a machine-measured post-filter hematocrit- and is typically classified as a cross-sectional investigational study in the context of diagnostic or method comparison research.

Вмешательства

  • Другое Calculated Post-Filter Hematocrit
    using the formula: HCTpost=HCTpre/(FF(HCTpre-1)+1)
  • Другое Measured Post-Filter Hematocrit
    Measured from blood sample taken from CRRT machine

Первичные конечные точки

  • Agreement between measured and calculated post-filter hematocrit values. [Срок оценки: Participation begins at consent and includes a single study procedure in which four post-filter blood samples are collected over ~40 minutes. Participation ends after the final draw. Generally, no longer than 1 day.]
Вторичные конечные точки (2)
  • Analyze the impact of CRRT settings on discrepancies between measured and calculated Filtration Fraction [Срок оценки: Participation begins at consent and includes a single study procedure in which four post-filter blood samples are collected over ~40 minutes. Participation ends after the final draw. Generally, no longer than one day.]
  • Subgroup analysis based on patient-specific factors [Срок оценки: Participation begins at consent and includes a single study procedure in which four post-filter blood samples are collected over ~40 minutes. Participation ends after the final draw.]

Критерии участия

Критерии включения

  • patients initiated on CRRT age equal than or greater to 18 years of age

Критерии исключения

  • patients on ECMO

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
Другое

Центры проведения

США · 1 центр
  • University of Iowa Hospitals and Clinics — Iowa City

Идентификаторы

NCT: NCT07293936 · 202412294

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗