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Идёт набор NCT06349577

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury

Без фазы С лечением Acute Kidney Injury Hemolysis Thrombocytopenia Surgery

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: Non-pulsatile blood flow, Pulsatile blood flow.
Кому может быть актуально
Состояния в реестре: Acute Kidney Injury, Hemolysis, Thrombocytopenia, Surgery. Базовые параметры: 18 лет — 85 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
США
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

Optimizing Pulsatility During Cardiopulmonary Bypass to Reduce Acute Kidney Injury: Randomized Controlled Trial

Обзор

The objective is to determine the effectiveness of pulsatile flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery. Investigators will also evaluate the safety and impact of pulsatile flow on clinical outcomes compared to non-pulsatile flow during cardiopulmonary bypass.

Подробное описание

Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass for cardiac surgery are both considered standard of care and allow surgeons to operate on the heart without movement. Pulsatile cardiopulmonary bypass produces variations in blood flow to produce a pulse similar to a normal beating heart. Non-pulsatile and pulsatile blood flow during cardiopulmonary bypass are approved as safe and effective ways to provide perfusion during cardiac surgery, but it is unknown whether there are differences in clinical outcomes after surgery. Acute kidney injury is common after cardiac surgery and may be caused by inadequate perfusion during cardiopulmonary bypass.

Specific Aim: The purpose of this study is to determine the effectiveness of pulsatile blood flow during cardiopulmonary bypass to reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Hypothesis: Pulsatile blood flow during cardiopulmonary bypass will reduce the incidence of acute kidney injury after cardiac surgery compared to non-pulsatile blood flow.

Вмешательства

  • Другое Non-pulsatile blood flow
    Non-pulsatile blood flow generated by constant centrifugal pump flow rate during cardiopulmonary bypass
  • Другое Pulsatile blood flow
    Pulsatile blood flow generated by variable centrifugal pump flow rate during cardiopulmonary bypass

Первичные конечные точки

  • Acute kidney injury [Срок оценки: From intensive care unit admission after surgery up to 7 days]
Вторичные конечные точки (5)
  • Acute kidney injury risk score [Срок оценки: On admission to the intensive care unit after surgery up to 24 hours after intensive care unit arrival]
  • Red blood cell units transfused [Срок оценки: After cardiopulmonary bypass up to 24 hours after intensive care unit arrival]
  • Platelet nadir [Срок оценки: On admission to the intensive care unit after surgery up to 7 days]
  • Discontinuation rate of cardiopulmonary bypass mode [Срок оценки: During cardiopulmonary bypass]
  • 30-day mortality [Срок оценки: From intensive care unit admission after surgery to hospital discharge, up to 30 days]

Критерии участия

Критерии включения

  • Able to provide informed consent
  • Scheduled for elective cardiac surgery with cardiopulmonary bypass

Критерии исключения

  • Emergency procedures
  • Scheduled for heart or lung transplantation
  • Scheduled for ventricular assist device implantation
  • Use of the Medtronic Elongated Once-Piece Arterial Cannula
  • Diagnosed with sepsis
  • Diagnosed with delirium
  • Experiencing hemodynamic instability (heart rate > 100 and systolic blood pressure < 90)
  • Requiring mechanical circulatory support
  • Requiring vasoactive medications

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • University of Colorado Hospital — Aurora

Публикации

  • Demirjian S, Bashour CA, Shaw A, Schold JD, Simon J, Anthony D, Soltesz E, Gadegbeku CA. Predictive Accuracy of a Perioperative Laboratory Test-Based Prediction Model for Moderate to Severe Acute Kidney Injury After Cardiac Surgery. JAMA. 2022 Mar 8;327(10):956-964. doi: 10.1001/jama.2022.1751. PMID 35258532
  • Khwaja A. KDIGO clinical practice guidelines for acute kidney injury. Nephron Clin Pract. 2012;120(4):c179-84. doi: 10.1159/000339789. Epub 2012 Aug 7. No abstract available. PMID 22890468
  • Tan A, Newey C, Falter F. Pulsatile Perfusion during Cardiopulmonary Bypass: A Literature Review. J Extra Corpor Technol. 2022 Mar;54(1):50-60. doi: 10.1182/ject-50-60. PMID 36380831

Идентификаторы

NCT: NCT06349577 · 23-0921 · 5K23HL151882

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗