An interventional study of PrismaLung+ and Invasive Mechanical Ventilation in Acute Respiratory Distress Syndrome and Acute Kidney Injury, sponsored by Vantive Health LLC. Recruiting at 10 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by Vantive Health LLC (formerly part of Baxter Healthcare Corporation) · Not applicable, Interventional, and Treatment
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Among 146 studies in Respiratory Distress Syndrome with a site in China — 54 open to participants now, 55 under way, 6 of them phase 3. Respiratory Distress Syndrome · China.
Among the 146 studies in Respiratory Distress Syndrome with a site in China, this one is the 44th largest by planned enrollment of the 81 interventional ones that give a count, is one of 13 that started in 2025, is one of 52 with no phase, reaches primary completion later than 33 of the 54 other live ones, and was the 128th registered.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 282 are open to participants now.
Browse Respiratory Distress Syndrome studies →54 of the 146 studies in Respiratory Distress Syndrome with a site in China are open now. Recruiting first, the newest first:
Southeast University, China · Sites in China
Ruijin Hospital · Sites in China
Ages 18+
Southeast University, China · Sites in China
Ages 18+
Southeast University, China · Sites in China
Ages 18+
Bin Du · Sites in China
Ages 18+
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 193 Respiratory Distress Syndrome studies recruiting now, 117 (61%) set no upper age limit and 48 (25%) stop at 75 or younger; 50 take children under 18; 9 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
146 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 16 · Phase 3 7 · Phase 4 5
First in 2006; this study’s year is marked. 13 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 99 is above the median of 60 across 822 interventional studies indexed under Respiratory Distress Syndrome.
Median enrollment 100 across the 81 interventional studies, 139 across the 65 observational. Of the 52 that completed or were terminated, 3 (6%) have results posted.
This tab as a report to print or save as PDF → With an account.
11 of 146 have an industry lead sponsor. The 10 most frequent:
This study is registered under Vantive Health LLC, one of the names counted as Baxter Healthcare Corporation. Under that name alone:
Vantive Health LLC is the lead sponsor of 55 studies on the registry; 3 are open to participants now.
Baxter Healthcare Corporation has 2 studies filed under Respiratory Distress Syndrome — fewer than ten, so there is no comparison to draw.
17 of the studies in Respiratory Distress Syndrome with a site in China that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07342205Phase 3Shanghai University of Traditional Chinese MedicineA Study on the Treatment of Patients With Acute Lung Injury Caused by Sepsis Through Microbiota Transplantation | 2027-06 |
| NCT05624450Phase 3AstraZenecaEfficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen | 2027-11-04 |
| NCT07798154Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyEffect of Spontaneous Breathing in APRV Mode on Respiratory Physiology of ARDS Patients | 2026-11 |
| NCT07413094Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.Efficacy and Safety of YD0743 Treatment for Sepsis-Associated ARDS | 2026-12 |
| NCT06430554Zhongda HospitalPersonalized Ventilation Based on Ventilation-perfusion Mismatch and Lung Recruitability | 2026-12-30 |
Add all 17 to your calendar (.ics) → With an account.
Among the 146 studies in Respiratory Distress Syndrome with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive IMV combined with ECCO2R using PrismaLung+.
Device: PrismaLung+
Other: Invasive Mechanical Ventilation
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.
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.
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
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.
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)
The ratio of partial pressure of arterial oxygen (PaO2 in mmHg) to fraction of inspired oxygen (FiO2 in %), i.e., 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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 28 days after enrollment
28-day mortality
All-cause mortality and in-hospital mortality after enrollment.
Time frame: 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).
Time frame: 1 day of regaining consciousness, 28 days after enrollment.
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2027, 13 months after the start.
Of 271 interventional studies with no phase under Respiratory Distress Syndrome, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 13 months is below that.
How these figures are worked out, and which studies are left out of them.
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Respiratory Distress Syndrome →