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Идёт набор NCT07418242

Prognostic Value of Novel Biomarkers on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

— Наблюдательное Cardiac Surgery Associated - Acute Kidney Injury Critical Illness

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: Standard care "bundle".
Кому может быть актуально
Состояния в реестре: Cardiac Surgery Associated - Acute Kidney Injury, Critical Illness. Базовые параметры: 18 лет — 90 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
Китай
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

Prognostic Value of Novel Biomarker on Adverse Renal Outcomes in High-Risk Cardiac Surgery Patients

Обзор

This project aims to detect novel biomarkers from preoperative and early postoperative serum and urine samples of patients to screen and analyze the risk factors for predicting adverse postoperative renal outcomes in high-risk patients in cardiac surgery.

Подробное описание

This project will prospectively collect all high-risk individuals who underwent cardiac surgery, collect medical history, laboratory data and specimen test results, and test biomarkers in blood and urine specimens. Previously identified candidate biomarkers include the tumor necrosis factor-like weak inducer of apoptosis receptor (TWEAKR), galectin-9 (Gal-9), perilipin-2 (Plin2), and CCN family member 1, among others. The occurrence of postoperative AKI will be the primary endpoint of the study. The variable factors that can be used to predict and warn the main research endpoints at an early stage were screened through methods such as logistic regression, and their non-inferiority compared with traditional markers was tested. This study will facilitate early clinical identification and early warning of AKI, early implementation of preventive measures and intervention strategies, thereby improving the prognosis of patients and improve the overall safety and success rate of cardiac surgery.

Вмешательства

  • Другое Standard care "bundle"
    The management for AKI patients were performed by implementing a standard care "bundle" suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline.

Первичные конечные точки

  • AKI occurrence within 7 days [Срок оценки: 7 days]
Вторичные конечные точки (10)
  • Moderate and severe AKI occurrence within 7 days [Срок оценки: 7 days]
  • AKI occurrence within 48 hours [Срок оценки: 48 hours]
  • AKI occurrence within 3 days [Срок оценки: 3 days]
  • Major adverse kidney events [Срок оценки: Perioperative]
  • Receipt of renal replacement treatment [Срок оценки: Perioperative]
  • Mortality [Срок оценки: 30 days]
  • length of stay in the ICU [Срок оценки: Perioperative]
  • Length of stay in the hospital [Срок оценки: Perioperative]
  • The number of days of use and cumulative dose of vasoactive drugs [Срок оценки: Perioperative]
  • AKI on CKD [Срок оценки: Perioperative]

Критерии участия

Adult patients were included in the study if they were scheduled for elective open chest cavity cardiac surgeries, with or without the use of cardiopulmonary bypass (CPB). Inclusion criteria required that patients undergoing surgery with CPB must have at least one AKI risk factor, whereas those undergoing surgery without CPB needed to have at least two AKI risk factors.

The AKI risk factors were as follows:

  • age >70 years;
  • 30 < estimated glomerular filtration rate (eGFR) <60 mL·min-1·1.73 m-2;
  • diabetes mellitus, proteinuria;
  • a history of congestive heart failure within the previous year;
  • a left ventricular ejection fraction of 40% or lower;
  • prior cardiac surgery;
  • combined coronary artery bypass/valve procedure;
  • urgent procedure;
  • preoperative intra-aortic balloon pump.

Критерии исключения

  • pre-existing chronic kidney disease (preoperative estimated glomerular filtration rate \[eGFR\] < 30 mL/min/1.73 m2);
  • previous RRT before cardiac surgery;
  • present AKI at screening;
  • a history of kidney transplant or other kidney diseases;
  • known pregnancy;
  • multiple operation during the hospital stay;
  • being in a moribund state (with an anticipated likelihood of death within 48 hours).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Китай · 2 центра
  • Zhongshan hospital, Fudan university — Шанхай
  • Zhongshan hospital — Шанхай

Идентификаторы

NCT: NCT07418242 · B2025-549

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗