Crystalloid vs Colloid for Hemodynamics During Anesthesia Induction in TAVR Patients

Официальное название

The Impact of Different Preload Strategies on Hemodynamics During Anesthesia Induction in TAVR Patients

Обзор

The purpose of this study is to evaluate whether the administration of 5 ml/kg of colloid solution prior to anesthesia induction, compared with 5 ml/kg of lactated Ringer's solution, can reduce hemodynamic fluctuations during the induction period (defined as the first 15 minutes after induction) in patients undergoing Transcatheter Aortic Valve Replacement (TAVR).

Вмешательства

• Препарат Hydroxyethyl starch 130/0.4
  5 ml/kg of hydroxyethyl starch 130/0.4 electrolyte injection is administered by infusion pump over 15 minutes before anesthesia induction.
• Препарат Lactate Ringer's Solution
  5 ml/kg of sodium lactate Ringer's solution is administered before anesthesia induction.

Первичные конечные точки

• The area under curve (AUC) of the change in mean arterial pressure from baseline during the induction period. [Срок оценки: induction period, at an average of 15 minutes]

Вторичные конечные точки (8)

• Incidence of post-induction hemodynamic instability, defined as arterial pressure (MAP)< 65 mmHg or a decrease of more than 20% from baseline within 15 minutes after induction. [Срок оценки: 15 minutes after induction]
• Intraoperative use of vasoactive drugs. [Срок оценки: Intraoperative period, at an average of 2 hours]
• Sequential Organ Failure Assessment(SOFA )score on the first postoperative day [Срок оценки: The first postoperative day, at 24 hours after surgery]
• Length of hospital stay. [Срок оценки: The duration of the patient's hospitalization after the initial surgery, at an average of 5 days.]
• Proportion of patients admitted to the intensive care unit (ICU) after surgery [Срок оценки: During the postoperative period prior to discharge (at an average of 5 days)]
• In-hospital all-cause mortality [Срок оценки: During the postoperative period prior to discharge (at an average of 5 days)]
• All-cause mortality within 30 days postoperatively [Срок оценки: 30 days after surgery]
• Proportion of patients receiving renal replacement therapy during the 30-day postoperative observation period [Срок оценки: 30 days after surgery]

Критерии участия

Критерии включения

• Age ≥ 18 years;
• Patients scheduled to undergo elective TAVR under general anesthesia;

Критерии исключения

• Allergy to hydroxyethyl starch, its components, and/or sodium lactate Ringer's solution, or a history of colloidal allergy;
• Severe cardiac dysfunction (ejection fraction\[EF\] < 35%);
• Severe renal dysfunction (creatinine > 132 μg/L and/or requiring renal replacement therapy);
• Morbid obesity (body mass index\[BMI\] > 37.5 kg/m² or > 32.5 kg/m² with metabolic diseases);
• Severe hepatic dysfunction ;
• Severe electrolyte disturbances ;
• Patients with preoperative intracranial hypertension requiring dehydration therapy;
• Expected postoperative hospital stay < 24 hours;
• Patients scheduled for multiple surgeries during this hospitalization.

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

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07329660 · XJH-A-20250824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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