Меню
Набор скоро начнётся NCT07332637

Association Between Early FiO₂ Exposure and Changes in the Uric Acid/Albumin Ratio in Septic ICU Patients

— Наблюдательное Hyperoxia / High FiO₂ Exposure Uric Acid/Albumin Ratio (UAR)

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: Oxygen Exposure (Fraction of Inspired Oxygen, FiO₂) - Standard of Care (Observational, No Experimental Intervention).
Кому может быть актуально
Состояния в реестре: Hyperoxia / High FiO₂ Exposure, Uric Acid/Albumin Ratio (UAR). 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 →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Evaluation of the Relationship Between 0-24-Hour Fraction of Inspired Oxygen (FiO₂) Exposure and Changes in the Uric Acid/Albumin Ratio in Intensive Care Unit Patients Diagnosed With Sepsis

Обзор

This prospective, non-interventional study aims to investigate the relationship between early oxygen exposure and oxidative stress in adult intensive care unit (ICU) patients diagnosed with sepsis or septic shock. Fraction of inspired oxygen (FiO₂) levels administered during the first 24 hours of ICU admission will be evaluated in relation to changes in the uric acid/albumin ratio (UAR), a biochemical marker reflecting oxidative burden and inflammation. Serum uric acid and albumin levels will be measured at ICU admission and at 24 hours, and the percentage change in UAR (ΔUAR%) will be calculated. Associations between FiO₂ exposure parameters and ΔUAR% will be analyzed, along with secondary outcomes including 28-day mortality and oxygenation indices. The findings may help clarify whether excessive oxygen therapy contributes to oxidative stress and whether UAR can serve as an accessible biomarker of oxygen-related oxidative injury in septic ICU patients.

Вмешательства

  • Другое Oxygen Exposure (Fraction of Inspired Oxygen, FiO₂) - Standard of Care (Observational, No Experimental Intervention)
    This study does not involve an experimental intervention. Patients will receive oxygen therapy as part of standard clinical care according to routine intensive care unit protocols and clinical indications. Fraction of inspired oxygen (FiO₂) levels administered during the first 24 hours of ICU admission will be recorded from ventilator and oxygen delivery system data. No changes will be made to patients' diagnostic, therapeutic, or oxygen administration practices. The study is purely observationa

Первичные конечные точки

  • Change in Uric Acid/Albumin Ratio in Relation to Early FiO₂ Exposure [Срок оценки: From ICU admission (0 hour) to 24 hours after admission]

Критерии участия

Критерии включения

  • Adult patients aged 18 years or older
  • Admission to the intensive care unit with a diagnosis of sepsis according to Sepsis-3 criteria
  • Receipt of oxygen therapy with FiO₂ ≥ 0.3 during ICU stay
  • Availability of serum uric acid, albumin, and lactate measurements and calculated SOFA scores at ICU admission
  • Availability of serum uric acid and albumin levels both at ICU admission (baseline) and at 24 hours
  • Provision of informed consent by the patient or a legally authorized representative

Критерии исключения

  • Age younger than 18 years
  • Pregnant or breastfeeding women
  • Chronic kidney disease or receipt of renal replacement therapy
  • Advanced liver failure (Child-Pugh class C)
  • Receipt of albumin infusion within the previous 24 hours
  • Use of medications that affect uric acid metabolism (e.g., allopurinol, febuxostat, rasburicase)
  • History of active gout attack or malignancy-related hyperuricemia
  • Missing serum uric acid or albumin measurements at baseline or 24 hours
  • Inability to obtain informed consent from the patient or a legally authorized representative

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • Katakam SN, Cherukuri M, Kada M, Hanji P, Kudru CU. The Prognostic Significance of Serum Uric Acid in Sepsis: A Comparative Study on Adult Patients. Indian J Crit Care Med. 2025 May;29(5):407-412. doi: 10.5005/jp-journals-10071-24968. Epub 2025 May 8. PMID 40416537
  • Ertan OES, Gokce O, Bal C, Kocaturk E, Ertan O, Mutluay R. Investigation of the Relationship Between Serum Uric Acid-to-Albumin Ratio and 28-Day Mortality in Patients With and Without Acute Kidney Injury. J Acute Med. 2024 Dec 1;14(4):152-159. doi: 10.6705/j.jacme.202412_14(4).0003. PMID 39624148

Идентификаторы

NCT: NCT07332637 · 329-2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗