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

Vantive Health LLC99 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome Acute Kidney Injury

Interventions

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.

Invasive Mechanical VentilationOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

NOT_YET_RECRUITING

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

NOT_YET_RECRUITING

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, China

NOT_YET_RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

NOT_YET_RECRUITING

Zhongda Hospital Southeast University

Nanjing, Jiangsu, China

NOT_YET_RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

NOT_YET_RECRUITING

ZhongShan Hospital Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

NOT_YET_RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT_YET_RECRUITING

Sir Run Run Shaw Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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: 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.

Time frame: 2 hours after treatment

Secondary Outcomes

CO2 clearance (in the experimental group only)

Blood sampled pre- and post-PrismaLung+ filter to calculate CO2 clearance based on blood gas analysis results.

Time frame: 2 hours and 24 hours after treatment

Changes in Blood Gas Indexes

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.