Acute Respiratory Distress SyndromeSPARENCT07326215
A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
A study testing PrismaLung+ and Invasive Mechanical Ventilation in people with Acute Respiratory Distress Syndrome and Acute Kidney Injury, run by Vantive Health LLC at 10 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome, Acute Kidney Injury
- What is being tested?
- PrismaLung+ and Invasive Mechanical Ventilation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 10 sitesChina
- Study dates
- 11 Dec 2025to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Global CORP Clinical Trials Disclosure contact
10 sites in 1 country
China10 sites, 10 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
Jun Duan
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Chun Pan
- Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510630
Ling Sang
- Recruiting
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Xia Zheng
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310016
Feng Guo
- Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
Mingyan Zhao
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Zhenguo Zeng
- Recruiting
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210009
Ling Liu
- Recruiting
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Ming Zhong
- Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053
Jun Jin
About this study
Official title: 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.
- Being tested
- PrismaLung+, Invasive Mechanical Ventilation
- Medical subject headings
- Respiratory Distress Syndrome, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving IMV combined with ECCO2R | Experimental | Patients will receive IMV combined with ECCO2R using PrismaLung+. Receives: Device: PrismaLung+ |
| Patients receiving IMV alone | Active comparator | Not described Receives: Other: Invasive Mechanical Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours after treatment
Secondary outcomes (13)
CO2 clearance (in the experimental group only)
Blood sampled pre- and post-PrismaLung+ filter to calculate CO2 clearance based on blood gas analysis results.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days after enrollment
28-day mortality
All-cause mortality and in-hospital mortality after enrollment.
Measured: 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).
Measured: 1 day of regaining consciousness, 28 days after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start11 Dec 2025
- Primary completion31 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326215
- Sponsor's protocol ID
- BXU614243
- Acronym
- SPARE
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07326215
- Acronym / sponsor ID
- SPARE / BXU614243
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients receiving IMV combined with ECCO2R | Experimental | Device: PrismaLung+Patients will receive IMV combined with ECCO2R using PrismaLung+. |
| Patients receiving IMV alone | Active comparator | Other: Invasive Mechanical Ventilation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Patients receiving IMV combined with ECCO2R |
| Invasive Mechanical VentilationAccording 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. | Other | Patients receiving IMV alone |
Primary outcome
The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment.
Time frame: 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.
13 secondary outcomes
CO2 clearance (in the experimental group only)
Time frame: 2 hours and 24 hours after treatment
Changes in Blood Gas Indexes
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Oxygenation Indexes (PaO2/FiO2)
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Ventilatory Parameters
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Ventilatory Parameters
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Ventilatory Parameters
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Ventilatory Parameters
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Ventilatory Parameters
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Changes in Ventilatory Parameters
Time frame: 2 hours, 4 hours, 8 hours, 12 hours, 24 hours, 2 days, 3 days, 7 days after treatment
Ventilator-Free Days
Time frame: 28 days after enrollment
Days of ICU stay
Time frame: 28 days after enrollment
28-day mortality
Time frame: 28 days after enrollment
Quality of life (QoL)
Time frame: 1 day of regaining consciousness, 28 days after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Global CORP Clinical Trials Disclosure contact
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrismaLung+ and Invasive Mechanical Ventilation in people with Acute Respiratory Distress Syndrome and Acute Kidney Injury, run by Vantive Health LLC at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Global CORP Clinical Trials Disclosure (+1 2249484283, Global.CORP.ClinicalTrialsDisclosure@vantive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment. (time frame: 2 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.