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Набор скоро начнётся NCT07722325

Venous Return Pressure Gradient as a Predictor of Acute Kidney Injury

Наблюдательное AKI - Acute Kidney Injury

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: No study intervention.
Кому может быть актуально
Состояния в реестре: AKI - Acute Kidney Injury. 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 →
Официальное название

Venous Return Pressure Gradient Predicts Acute Kidney Injury Onset and Progression

Обзор

Acute kidney injury (AKI) is a common and serious complication in the ICU. Current diagnostic indicators (such as creatinine and urine output) exhibit significant lag, and specific hemodynamic predictive markers are lacking. The venous return pressure gradient (Pmsf-CVP), based on Guyton's theory, reflects the driving pressure for venous return; however, its value in the early warning of AKI remains unclear. This study aims to investigate the predictive value of the venous return pressure gradient for the onset and progression of AKI in ICU patients, and to clarify its effectiveness as an AKI risk warning indicator. Patients admitted to the ICU within 48 hours with risk factors for AKI (including sepsis, shock, major surgery, underlying diseases, etc.) who have radial artery catheterization and can undergo hemodynamic monitoring will be enrolled. Those undergoing maintenance dialysis/CRRT, ECMO support, or with missing core data precluding calculation of Pmsf-CVP or AKI assessment will be excluded. The venous return pressure gradient (Pmsf-CVP, mmHg) will be measured within 48 hours of ICU admission using the transient stop-flow arm arterial-venous equilibrium pressure method. The primary outcome is to evaluate the association between the venous return pressure gradient level and AKI occurrence. Secondary outcomes include correlation analyses between the venous return pressure gradient level and serum creatinine and urine output within 48 hours of ICU admission, among others.

Вмешательства

  • Другое No study intervention
    No study intervention. This is an observational cohort study using routine hemodynamic monitoring data (Pmsf and CVP) collected during standard clinical care.

Первичные конечные точки

  • Acute Kidney Injury occurrence [Срок оценки: Within 48 hours of ICU admission]
Вторичные конечные точки (8)
  • Persistent Acute Kidney Injury [Срок оценки: Within 48 hours after AKI occurrence during the ICU stay]
  • AKI severity grade [Срок оценки: At the time of maximum AKI stage during the ICU stay, up to 28 days]
  • In-hospital mortality [Срок оценки: From ICU admission to hospital discharge, up to 90 days]
  • Total length of hospital stay [Срок оценки: From hospital admission to discharge or death, up to 90 days]
  • Correlation between venous return pressure gradient and serum creatinine [Срок оценки: Within 48 hours of ICU admission]
  • Correlation between venous return pressure gradient and lactate [Срок оценки: Within 48 hours of ICU admission]
  • Duration of mechanical ventilation [Срок оценки: From intubation to first successful extubation]
  • Length of ICU stay [Срок оценки: From ICU admission to ICU discharge]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Admitted to the intensive care unit (ICU) within 48 hours
  • Central venous catheter in place for continuous central venous pressure (CVP) monitoring
  • Radial artery catheter in place for hemodynamic monitoring including mean systemic filling pressure (Pmsf)
  • No acute kidney injury (AKI) at ICU admission according to KDIGO criteria

Критерии исключения

  • Maintenance hemodialysis or continuous renal replacement therapy (CRRT) prior to ICU admission
  • Previous kidney transplantation
  • Pregnancy
  • Extracorporeal membrane oxygenation (ECMO) support at ICU admission
  • Incomplete core hemodynamic data precluding calculation of venous return pressure gradient (Pmsf-CVP) or AKI assessment

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

  • Eskesen TG, Wetterslev M, Perner A. Systematic review including re-analyses of 1148 individual data sets of central venous pressure as a predictor of fluid responsiveness. Intensive Care Med. 2016 Mar;42(3):324-332. doi: 10.1007/s00134-015-4168-4. Epub 2015 Dec 9. PMID 26650057
  • Magder S. The use of Guyton's approach to the control of cardiac output for clinical fluid management. Ann Intensive Care. 2024 Jul 4;14(1):105. doi: 10.1186/s13613-024-01316-z. PMID 38963533
  • Chen X, Wang X, Honore PM, Spapen HD, Liu D. Renal failure in critically ill patients, beware of applying (central venous) pressure on the kidney. Ann Intensive Care. 2018 Sep 20;8(1):91. doi: 10.1186/s13613-018-0439-x. PMID 30238174
  • Badin J, Boulain T, Ehrmann S, Skarzynski M, Bretagnol A, Buret J, Benzekri-Lefevre D, Mercier E, Runge I, Garot D, Mathonnet A, Dequin PF, Perrotin D. Relation between mean arterial pressure and renal function in the early phase of shock: a prospective, explorative cohort study. Crit Care. 2011;15(3):R135. doi: 10.1186/cc10253. Epub 2011 Jun 6. PMID 21645384
  • Wonnacott A, Meran S, Amphlett B, Talabani B, Phillips A. Epidemiology and outcomes in community-acquired versus hospital-acquired AKI. Clin J Am Soc Nephrol. 2014 Jun 6;9(6):1007-14. doi: 10.2215/CJN.07920713. Epub 2014 Mar 27. PMID 24677557
  • Turgut F, Awad AS, Abdel-Rahman EM. Acute Kidney Injury: Medical Causes and Pathogenesis. J Clin Med. 2023 Jan 3;12(1):375. doi: 10.3390/jcm12010375. PMID 36615175
  • Rossiter A, La A, Koyner JL, Forni LG. New biomarkers in acute kidney injury. Crit Rev Clin Lab Sci. 2024 Jan;61(1):23-44. doi: 10.1080/10408363.2023.2242481. Epub 2023 Sep 5. PMID 37668397
  • Siew ED, Davenport A. The growth of acute kidney injury: a rising tide or just closer attention to detail? Kidney Int. 2015 Jan;87(1):46-61. doi: 10.1038/ki.2014.293. Epub 2014 Sep 17. PMID 25229340

Идентификаторы

NCT: NCT07722325 · IRB No. 321 (2026)

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗