Acute Kidney Injury, Acute Respiratory Distress Syndrome
Conditions
Brief summary
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.
Interventions
DEVICEPrismaLung+
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.
OTHERInvasive 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 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.
Sponsors
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old. 2. Invasive mechanical ventilation patients with PaCO2 \> 50 mmHg and pH \< 7.4 under LPV strategy (RR \< 25/min, DP \< 15 cmH2O). 3. Expected to be able to tolerate ECCO2R for a minimum of 2h. 4. 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.
Exclusion criteria
1. Body weight \< 30 kg. 2. Has a contraindication for systemic anticoagulation with heparin according to the Investigator. 3. Patient unable to establish extracorporeal circulation access or has a high risk of establishing such access, as judged by the Investigator. 4. Allergic to the investigational device/tubing, and/or to the CRRT filters/tubing if combined with CRRT treatment. 5. Expected to require extracorporeal membrane oxygenator (ECMO) treatment within 24h after enrollment. 6. Patient's primary disease is expected to worsen rapidly or require other surgical intervention within 24h after enrollment. 7. Diagnosed as brain dead or in a vegetative state. 8. Pregnant and/or breastfeeding. 9. 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. 10. Patients is considered as unsuitable for participating in the study, as judged by the Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment. | 2 hours after treatment | Percent decrease (%) of PaCO2 from baseline based on arterial blood gas 2h after treatment initiation. Must meet the following requirements for data collection: 1. maintained LPV (RR \< 25/min, DP \< 15 cmH2O) with consistent ventilatory parameters with baseline; 2. blood flow rate (Qb) of 300 to 450 mL/min; 3. sweep gas flow rate of 10 L/min. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CO2 clearance (in the experimental group only) | 2 hours and 24 hours after treatment | Blood sampled pre- and post-PrismaLung+ filter to calculate CO2 clearance based on blood gas analysis results. |
| Changes in Blood Gas Indexes | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment | 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. |
| Changes in Oxygenation Indexes (PaO2/FiO2) | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment | The ratio of partial pressure of arterial oxygen (PaO2 in mmHg) to fraction of inspired oxygen (FiO2 in %), i.e., PaO₂/FiO₂. |
| Changes in Ventilatory Parameters | 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment | 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. |
| Ventilator-Free Days | 28 days after enrollment | 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: * The total respiratory rate of the patient is higher than that set in the assist-control mode during mechanical ventilation, or the mechanical ventilation mode requires the patient to breathe spontaneously. * No invasive respiratory support is provided. |
| Days of ICU stay | 28 days after enrollment | The span of time during which the patient receives treatment and care in the ICU within 28 days after treatment initiation. |
| 28-day mortality | 28 days after enrollment | All-cause mortality and in-hospital mortality after enrollment. |
| Quality of life (QoL) | 1 day of regaining consciousness, 28 days after enrollment. | 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). |
Countries
China
Contacts
CONTACTGlobal CORP Clinical Trials Disclosure
Outcome results
None listed