PrismaLung+ carbon dioxide removal for ventilated ICU patients

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

This study will test whether adding PrismaLung+, a device that removes CO2 from the blood, helps adults on invasive mechanical ventilation who have high carbon dioxide levels.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 99 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Vantive Health LLC (industry)
• Locations: 10 sites (Beijing, Beijing Municipality and 9 other locations)
• Trial ID: NCT07326215 on ClinicalTrials.gov

What this trial studies

PrismaLung+ is a sterile, single-use device designed to remove carbon dioxide from venous blood by diffusion across a membrane. In this prospective, open-label, randomized controlled study, critically ill adults on invasive mechanical ventilation with elevated PaCO2 and acidemia will be randomized 2:1 to receive extracorporeal CO2 removal with PrismaLung+ plus standard ventilation or standard ventilation alone. The trial will track physiological CO2 removal, ventilator settings, and safety outcomes such as bleeding and access complications. The protocol requires patients to be able to tolerate at least 2 hours of ECCO2R and uses lung-protective ventilation strategies throughout.

Who should consider this trial

Good fit: Adults (≥18) on invasive mechanical ventilation with PaCO2 > 50 mmHg and pH < 7.4 while on lung-protective ventilation who can tolerate ECCO2R and provide informed consent (or have a legal representative consent).

Not a fit: Patients with contraindications to systemic anticoagulation, inability or high risk to establish extracorporeal access, allergies to device components, very low body weight (<30 kg), or who require immediate ECMO are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, PrismaLung+ could lower blood CO2 and allow gentler ventilator settings, potentially reducing ventilator-related lung injury.

How similar studies have performed: Previous ECCO2R studies have shown consistent physiologic CO2 removal and the potential to spare ventilation, but large trials have produced mixed results on clear clinical outcome benefits.

Eligibility criteria

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.

Where this trial is running

Beijing, Beijing Municipality and 9 other locations

• 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)

Study contacts

• Study coordinator: Global CORP Clinical Trials Disclosure

Conditions: Acute Respiratory Distress Syndrome, Acute Kidney Injury