A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+

Официальное название

A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ in Chinese Critically Ill Patients: a Prospective Randomized Controlled Clinical Trial

Обзор

PrismaLung+ is a sterile, single-use medical device aimed at performing partial removal of carbon dioxide (CO2) from the patient's venous blood via diffusion through a membrane. The goal of this prospective, open label, randomized controlled study is to evaluate the efficacy and safety of PrismaLung+ on extracorporeal carbon dioxide removal (ECCO2R) in critically ill patients under invasive mechanical ventilation (IMV). Patients will be randomized to receive either IMV combined with ECCO2R (using PrismaLung+) in the study group or IMV alone in the control group, at a ratio of 2:1.

Вмешательства

• Устройство PrismaLung+
  PrismaLung+ is a medical device that provides ECCO2R as a stand-alone therapy or in combination with CRRT. The planned treatment duration with PrismaLung+ for patients in the study group is 7 days. However, the Investigator can discontinue PrismaLung+ treatment before 7 days if ECCO2R is no longer required. Following the 7-day treatment period, the Investigator will assess the patient's condition to determine whether to continue ECCO2R. Patients will require systemic anticoagulation with heparin
• Другое Invasive Mechanical Ventilation
  According to the standard clinical practice of IMV, oral or nasal endotracheal intubation can be used for IMV. The initial mode of IMV and ventilatory parameters will be determined based on the patient's condition, and an appropriate patient-centered LPV approach will be selected to adjust the ventilatory parameters to achieve the study LPV strategy. Appropriate treatments other than ECCO2R will be provided for this group. Continuous renal replacement therapy may be administered concurrently to

Первичные конечные точки

• The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment. [Срок оценки: 2 hours after treatment]

Вторичные конечные точки (12)

• CO2 clearance (in the experimental group only) [Срок оценки: 2 hours and 24 hours after treatment]
• Changes in Blood Gas Indexes [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Oxygenation Indexes (PaO2/FiO2) [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Ventilatory Parameters [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Ventilatory Parameters [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Ventilatory Parameters [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Ventilatory Parameters [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Ventilatory Parameters [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Changes in Ventilatory Parameters [Срок оценки: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment]
• Ventilator-Free Days [Срок оценки: 28 days after enrollment]
• Days of ICU stay [Срок оценки: 28 days after enrollment]
• 28-day mortality [Срок оценки: 28 days after enrollment]

Критерии участия

Критерии включения

• Age ≥ 18 years old.
• Invasive mechanical ventilation patients with PaCO2 > 50 mmHg and pH < 7.4 under LPV strategy (RR < 25/min, DP < 15 cmH2O).
• Expected to be able to tolerate ECCO2R for a minimum of 2h.
• Patients signed a written informed consent; if the right to consent cannot be exercised due to loss of decision-making ability or impairment of consciousness, the legal representative or immediate family member must sign the informed consent document after fully understanding the research content.

Критерии исключения

• Body weight < 30 kg.
• Has a contraindication for systemic anticoagulation with heparin according to the Investigator.
• Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator.
• Allergic to the investigational device/tubing, and/or to the CRRT filters/tubing if combined with CRRT treatment.
• Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment.
• Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment.
• Diagnosed as brain dead or in a vegetative state.
• Pregnant and/or breastfeeding.
• Plans to participate in other device studies within 30 days before screening or during the study period or has completed any clinical drug study within 5 half lives of the investigational drug.
• Patients is considered as unsuitable for participating in the study, as judged by the Investigator.

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

Лечение

Центры проведения

Китай · 10 центров

• China-Japan Friendship Hospital — Пекин
• The First Affiliated Hospital of Guangzhou Medical University — Гуанчжоу
• The University of Hong Kong-Shenzhen Hospital — Шэньчжэнь
• The First Affiliated Hospital of Harbin Medical University — Харбин
• Zhongda Hospital Southeast University — Нанкин
• The First Affiliated Hospital of Nanchang University — Nanchang
• ZhongShan Hospital Fudan University — Шанхай
• Sichuan Provincial People's Hospital — Чэнду
• … и ещё 2 центра

Идентификаторы

NCT: NCT07326215 · BXU614243

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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