Restricted or Liberal Fluid for Haemodynamic Resuscitation in Sepsis
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: Vasopressors, Fluids.
- Кому может быть актуально
- Состояния в реестре: Septic Shock, Fluid Resuscitation. 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
Fluid Restricted Resuscitation in Sepsis With Hypotension Meta-Analysis (FRESHLY): Individual Patient Data Met-analysis of the ARISE FLUIDS, CLASSIC, CLOVERS and EVIS Trials
Обзор
A prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
Подробное описание
This study is a prospective, individual patient data meta-analysis (IPDMA) of four multicentre, open-label, randomised clinical trials of initial haemodynamic resuscitation in patients with septic shock.
The investigators will include four multicentre, open-label, randomised, clinical trials:
* Australasian Resuscitation in Sepsis Evaluation Fluids of Vasopressors in Emergency Department Sepsis (ARISE FLUIDS) trial conducted in Australia and New Zealand. ClinicalTrials.gov identifier NCT04569942 * Conservative versus Liberal Approach to fluid therapy of Septic Shock in intensive Care (CLASSIC) trial conducted in seven European countries. ClinicalTrials.gov identifier NCT03668236 * Crystalloid Liberal or Vasopressors Early (CLOVERS) trial conducted in the United States. ClinicalTrials.gov identifier NCT03434028 * Early Vasopressors in Sepsis (EVIS) trial conducted in the United Kingdom. ClinicalTrials.gov identifier NCT05179499
All four trials have all received relevant approval from a research ethics committee with a locally appropriate method of obtaining consent. These trials are prospectively chosen prior to the results of any individual trial being known because they are investigating the same broad question in patients with acute septic shock across several countries. The investigators of these trials collaborated to harmonise data and outcomes as far as possible across all trials to facilitate an IPDMA.
The aims to provide high level evidence to address the question of whether a fluid sparing/early vasopressor approach or a liberal fluid/later vasopressor approach to initial haemodynamic resuscitation in septic shock results in improved outcomes, including mortality.
Вмешательства
- Другое Vasopressors
A haemodynamic resuscitation strategy based upon the restriction of IV fluids (by either volume or rate of infusion) with initiation or change of rate of vasopressors if required to meet perfusion targets - Другое Fluids
A strategy of resuscitation with intravenous fluids as the primary intervention to achieve perfusion targets with subsequent initiation or change of rate of vasopressors if required.
Первичные конечные точки
- All-cause mortality at 90 days post randomisation [Срок оценки: 90 days]
Вторичные конечные точки (7)
- Time from randomisation to death [Срок оценки: Up to day 90]
- Incidence of mechanical ventilation [Срок оценки: from randomisation until day 90 post-randomisation]
- Incidence of acute renal replacement therapy [Срок оценки: from randomisation until day 90 post-randomisation]
- Days alive free of organ support at 28 days post randomisation [Срок оценки: from randomisation until day 28 post-randomisation]
- Duration of hospital stay [Срок оценки: From randomisation until day 90 post-randomisation]
- Incidence of serious adverse events [Срок оценки: from randomisation until day 90 post-randomisation]
- Duration of intensive care unit (ICU) stay [Срок оценки: From randomisation until day 90 post-randomisation]
Критерии участия
Критерии включения
Participants of the ARISE FLUIDS, CLASSIC, CLOVERS \& EVIS trials who had:
- Suspected or proven infection
- Systolic blood pressure (SBP) <100 mm Hg OR mean arterial pressure (MAP) <65 mm Hg
- Lactate ≥ 2.0 mmol/L
- Requirement for vasopressors to meet perfusion targets
Критерии исключения
Participants not in the ARISE FLUIDS, CLASSIC, CLOVERS \& EVIS trials
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT05453565 · FRESHLY V1