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Набор скоро начнётся NCT07288944

Protocolised Management of Phosphate Replacement Trial

Без фазы С лечением Phosphate Deficiency Hypophosphatemia Protocol Optimization Critical Care, Intensive Care

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: Liberal Phosphate Replacement Protocol, Restrictive Phosphate Replacement Protocol.
Кому может быть актуально
Состояния в реестре: Phosphate Deficiency, Hypophosphatemia, Protocol Optimization, Critical Care, Intensive Care. 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
Список центров уточняется — проверьте первичный протокол.
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

A Comparison of Two Phosphate Replacement Protocols for Critically Ill Patients Treated in an Intensive Care Unit: a Cluster, Crossover, Comparative Effectiveness, Randomised, Controlled Trial

Обзор

The aim of this cluster, crossover, randomised controlled trial is to compare two standard arms of treatment for the replacement of phosphate in critically ill patients. We hypothesise that protocolised restricted phosphate replacement, compared to protocolised liberal phosphate replacement, will result in reduced administration of phosphate with similar clinical outcomes. All eligible Intensive Care Unit (ICU) patients will be included during their admission with the selected protocol for that period as per usual practice and treatment standards.

Подробное описание

This study looks to compare liberal and restrictive phosphate replacement protocols (each arm is a current "standard of care" already used in practice) to investigate whether restrictive phosphate replacement in critically ill patients leads to reduced phosphate administration and/or equivalent patient outcomes.

Derangements of serum phosphate concentrations are common among ICU patients; high and low levels variably associated with worse outcomes. The PROMPT trial will compare two standard arms of treatment for the replacement of phosphate in critically ill patients. Phosphate is currently replaced routinely in ICU's however there is not a standardised evidence-based guideline to effectively guide phosphate administration for ICU patients

This is a cluster, crossover, electronic medical record integrated, randomised, controlled trial. Sites (not patients) will be randomised to wither the liberal or restrictive phosphate replacement protocol for a 6-month period, followed by a 1-month washout period, before switching to the next protocol for the preceding 6-month period. The allocated phosphate replacement protocol will be updated in the electronic medical record to be followed; this process is already part of normal clinical practice.

Вмешательства

  • Другое Liberal Phosphate Replacement Protocol
    The liberal group, a recommendation for phosphate replacement would be given if the serum phosphate concentration was 0.79 mmol/L, but not if 0.80 mmol/L.
  • Другое Restrictive Phosphate Replacement Protocol
    The restrictive protocol will recommend phosphate replacement to commence at a threshold of 0.50 mmol/L, and the liberal protocol at 0.80 mmol/L.

Первичные конечные точки

  • non-inferiority for days alive and free of the intensive care unit (ICU) up to 30 days (DAF-ICU-30) [Срок оценки: 30 Days post study enrolment]
Вторичные конечные точки (7)
  • Phosphate usage [Срок оценки: individual arm and total quantities used over 12-month study period]
  • Patients receiving phosphate [Срок оценки: total proportion of patients receiving phosphate throughout 12-month study period]
  • Hospital Length of Stay [Срок оценки: hospital admission to hospital discharge throughout 12-month study period]
  • Hospital Mortality [Срок оценки: hospital admission to hospital discharge throughout 12-month study period]
  • cardiac rhythm disturbance [Срок оценки: ICU admission to ICU discharge, throughout 12-month study period]
  • Mechanical ventilation hours [Срок оценки: hospital admission to hospital discharge, throughout 12-month study period]
  • Tracheal reintubation [Срок оценки: hospital admission to hospital discharge, throughout 12-month study period]

Критерии участия

Критерии включения

  • All adult patients admitted to participating intensive care units during the study period.

Критерии исключения

  • There will be no specific exclusion criteria

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
Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Ramanan M, Tabah A, Affleck J, Edwards F, White KC, Attokaran A, Laupland K. Hypophosphataemia in Critical Illness: A Narrative Review. J Clin Med. 2024 Nov 26;13(23):7165. doi: 10.3390/jcm13237165. PMID 39685625
  • Sin JCK, Laupland KB, Ramanan M, Tabah A. Phosphate abnormalities and outcomes among admissions to the intensive care unit: A retrospective multicentre cohort study. J Crit Care. 2021 Aug;64:154-159. doi: 10.1016/j.jcrc.2021.03.012. Epub 2021 Apr 18. PMID 33906104

Идентификаторы

NCT: NCT07288944 · HREC/2025/MNH/121108

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗