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

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

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 Overview

• Status: Recruiting
• Conditions: Acute Kidney Injury; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: PrismaLung+; Other: Invasive Mechanical Ventilation

• Study Type: Interventional
• Enrollment (Estimated): 99
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Global CORP Clinical Trials Disclosure; Phone Number: +1 2249484283; Email: Global.CORP.ClinicalTrialsDisclosure@vantive.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • Not yet recruiting
      • China-Japan Friendship Hospital
      • Principal Investigator: Jun Duan
  • Guangdong
    • Guangzhou, Guangdong, China, 510630
      • Not yet recruiting
      • The First Affiliated Hospital of Guangzhou Medical University
      • Principal Investigator: Ling Sang
    • Shenzhen, Guangdong, China, 518053
      • Not yet recruiting
      • The University of Hong Kong-Shenzhen Hospital
      • Principal Investigator: Jun Jin
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150001
      • Not yet recruiting
      • The First Affiliated Hospital of Harbin Medical University
      • Principal Investigator: Mingyan Zhao
  • Jiangsu
    • Nanjing, Jiangsu, China, 210009
      • Not yet recruiting
      • Zhongda Hospital Southeast University
      • Principal Investigator: Ling Liu
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Not yet recruiting
      • The First Affiliated Hospital of Nanchang University
      • Principal Investigator: Zhenguo Zeng
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200032
      • Recruiting
      • Zhongshan Hospital Fudan University
      • Principal Investigator: Ming Zhong
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Not yet recruiting
      • Sichuan Provincial People's Hospital
      • Principal Investigator: Chun Pan
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Not yet recruiting
      • Sir Run Run Shaw Hospital Zhejiang University School of Medicine
      • Principal Investigator: Feng Guo
    • Hangzhou, Zhejiang, China, 310003
      • Not yet recruiting
      • the First Affiliated Hospital Zhejiang University School of Medicine
      • Principal Investigator: Xia Zheng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients receiving IMV combined with ECCO2R; Patients will receive IMV combined with ECCO2R using PrismaLung+.	Device: 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 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.
Active Comparator: Patients receiving IMV alone	Other: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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: maintained LPV (RR < 25/min, DP < 15 cmH2O) with consistent ventilatory parameters with baseline;; blood flow rate (Qb) of 300 to 450 mL/min;; sweep gas flow rate of 10 L/min.	2 hours after treatment

Secondary Outcome Measures

Outcome Measure	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	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: 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.	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.

Collaborators and Investigators

• Sponsor: Vantive Health LLC

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: December 9, 2025
• First Submitted That Met QC Criteria: December 23, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Renal Insufficiency; Respiratory Distress Syndrome; Acute Kidney Injury
• Other Study ID Numbers: BXU614243

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No