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NCT Number: NCT07326215

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

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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Key information

Conditions

Acute Respiratory Distress Syndrome Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Lung Diseases Male Urogenital Diseases Renal Insufficiency Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China-Japan Friendship Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. 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:

    • 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.

Secondary outcomes

  1. CO2 clearance (in the experimental group only)

    Time frame: 2 hours and 24 hours after treatment

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

  2. 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

    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.

  3. 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

    The ratio of partial pressure of arterial oxygen (PaO2 in mmHg) to fraction of inspired oxygen (FiO2 in %), i.e., PaO₂/FiO₂.

  4. 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 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.

  5. 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 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.

  6. 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 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.

  7. 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 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.

  8. 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 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.

  9. 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 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.

  10. Ventilator-Free Days

    Time frame: 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.

  11. Days of ICU stay

    Time frame: 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.

  12. 28-day mortality

    Time frame: 28 days after enrollment

    All-cause mortality and in-hospital mortality after enrollment.

  13. Quality of life (QoL)

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Global CORP Clinical Trials Disclosure

CONTACT

[email protected]

+1 2249484283

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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