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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving IMV combined with ECCO2R | Experimental | Patients will receive IMV combined with ECCO2R using PrismaLung+. |
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| Patients receiving IMV alone | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PrismaLung+ | Device | 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 during ECCO2R treatment. Continuous renal replacement therapy may be administered concurrently to patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease. |
| Measure | Description | Time Frame |
|---|---|---|
| The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment. | Percent decrease (%) of PaCO2 from baseline based on arterial blood gas 2h after treatment initiation. Must meet the following requirements for data collection:
| 2 hours after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| CO2 clearance (in the experimental group only) | Blood sampled pre- and post-PrismaLung+ filter to calculate CO2 clearance based on blood gas analysis results. | 2 hours and 24 hours after treatment |
| Changes in Blood Gas Indexes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Global CORP Clinical Trials Disclosure | Contact | +1 2249484283 | Global.CORP.ClinicalTrialsDisclosure@vantive.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Invasive Mechanical Ventilation | Other | 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 patients during the study, if needed, at the discretion of the Investigator. During the study, patients will be given active treatment for their primary disease. |
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Change in blood gas indexes before and after treatment based on arterial blood gas at different follow-up timepoints. Blood gas indexes include pH, PaO2, PaCO2, SaO2, standard bicarbonate (SB), actual bicarbonate (AB), and lactic acid.
| 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Oxygenation Indexes (PaO2/FiO2) | The ratio of partial pressure of arterial oxygen (PaO2 in mmHg) to fraction of inspired oxygen (FiO2 in %), i.e., PaO₂/FiO₂. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Ventilatory Parameters | Changes in respiratory rate (RR). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. RR refers to the number of breaths per minute of a ventilator, measured in breaths/min. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Ventilatory Parameters | Changes in tidal volume (VT). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. VT refers to the volume of air delivered by a ventilator, measured in mL. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Ventilatory Parameters | Changes in driving pressure (DP). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. DP refers to the driving pressure of a respiratory system, defined as tidal volume/respiratory system compliance. Respiratory system driving pressure = airway Pplat - PEEP, measured in cmH2O. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Ventilatory Parameters | Changes in positive end-expiratory pressure (PEEP). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. PEEP refers to the pressure applied by a ventilator that will remain in the airways at the end of exhalation, measured in cmH2O. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Ventilatory Parameters | Changes in plateau pressure (Pplat). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. Pplat refers to the airway plateau pressure, i.e., the airway pressure when airflow has ceased or is paused at the end of inspiration, measured in cmH2O. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Changes in Ventilatory Parameters | Changes in fraction of inspired oxygen (FiO2). The following definitions on ventilatory parameters are for reference and the specific parameters are based on the ventilator mode at each site. FiO2 refers to the fraction of oxygen in the delivered gas under monitoring, measured in percentage. | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment |
| Ventilator-Free Days | The number of days between successful weaning from mechanical ventilation and the end of follow-up (28 days after treatment). Weaning from mechanical ventilation refers to the removal of mechanical ventilation for respiratory support and the resumption of complete spontaneous breathing, after the primary disease is controlled and the ventilation and gas exchange functions are improved in patients under mechanical ventilation (referred to as weaning from mechanical ventilation). Instead of using mechanical ventilation for respiratory support, the respiratory load of the body is borne entirely by the patient's own respiratory capacity. Spontaneous breathing:
| 28 days after enrollment |
| Days of ICU stay | The span of time during which the patient receives treatment and care in the ICU within 28 days after treatment initiation. | 28 days after enrollment |
| 28-day mortality | All-cause mortality and in-hospital mortality after enrollment. | 28 days after enrollment |
| Quality of life (QoL) | During the trial, for patients who regain consciousness, the differences in quality-of-life scores will be evaluated based on EQ-5D-5L assessments at the time of awakening and on Day 28 (if the patients are still alive). | 1 day of regaining consciousness, 28 days after enrollment. |
| The First Affiliated Hospital of Guangzhou Medical University | Not yet recruiting | Guangzhou | Guangdong | 510630 | China |
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| The University of Hong Kong-Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518053 | China |
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| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150001 | China |
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| Zhongda Hospital Southeast University | Not yet recruiting | Nanjing | Jiangsu | 210009 | China |
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| The First Affiliated Hospital of Nanchang University | Not yet recruiting | Nanchang | Jiangxi | 330006 | China |
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| ZhongShan Hospital Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310003 | China |
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| Sir Run Run Shaw Hospital Zhejiang University School of Medicine | Not yet recruiting | Hangzhou | Zhejiang | 310016 | China |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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