Actively Recruiting
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
Led by Vantive Health LLC · Updated on 2026-02-17
99
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of the PrismaLung+ device for extracorporeal carbon dioxide removal (ECCO2R) in critically ill patients who require invasive mechanical ventilation (IMV). This prospective, open-label, randomized controlled study compares the combination of IMV with ECCO2R using PrismaLung+ to IMV alone. The study aims to better manage carbon dioxide levels in patients with conditions like acute respiratory distress syndrome and acute kidney injury. Participants will be randomly assigned to one of two groups: one group will receive IMV combined with ECCO2R using the PrismaLung+ device, while the control group will receive IMV alone. The PrismaLung+ treatment is planned to last up to 7 days, but investigators may stop the treatment earlier if ECCO2R is no longer needed. During ECCO2R, patients will receive systemic anticoagulation with heparin. Continuous renal replacement therapy may also be given alongside if necessary, based on the investigator's judgment. Throughout the study, researchers will monitor carbon dioxide levels and other blood gas and oxygenation indexes at multiple time points, from 2 hours after treatment up to 7 days. They will also track ventilatory parameters, ventilator-free days, length of ICU stay, 28-day mortality, and quality of life after regaining consciousness and at 28 days. The primary outcome is the percent decrease in partial pressure of carbon dioxide (PaCO2) from baseline after 2 hours of treatment. Participants will be closely observed during the study period, which starts December 2025 and ends August 2026.
CONDITIONS
Brief Title
A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years old or older
- Receiving invasive mechanical ventilation with PaCO2 greater than 50 mmHg and pH less than 7.4 under lung-protective ventilation strategy (respiratory rate less than 25/min, driving pressure less than 15 cmH2O)
- Expected to tolerate extracorporeal carbon dioxide removal for at least 2 hours
- Signed written informed consent or consent provided by legal representative or immediate family if patient lacks decision-making ability
You will not qualify if you...
- Body weight less than 30 kilograms
- Contraindication for systemic anticoagulation with heparin
- Unable or high risk to establish extracorporeal circulation access
- Allergy to PrismaLung+ device/tubing or CRRT filters/tubing if combined with CRRT
- Expected need for extracorporeal membrane oxygenation within 24 hours after enrollment
- Primary disease expected to worsen rapidly or require surgery within 24 hours after enrollment
- Diagnosed brain dead or in vegetative state
- Pregnant or breastfeeding
- Participation in other device studies within 30 days before screening or during study, or recent clinical drug study
- Considered unsuitable for participation by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive invasive mechanical ventilation (IMV). Some participants also receive extracorporeal carbon dioxide removal (ECCO2R) using the PrismaLung+ device for up to 7 days, with possible early discontinuation if ECCO2R is no longer required. Systemic anticoagulation with heparin is provided during ECCO2R treatment. Continuous renal replacement therapy may be administered concurrently if needed.
Continuous monitoring during treatment period
Trial Site Locations
Total: 10 locations
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Not Yet Recruiting
2
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510630
Not Yet Recruiting
3
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, China, 518053
Not Yet Recruiting
4
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Not Yet Recruiting
5
Zhongda Hospital Southeast University
Nanjing, Jiangsu, China, 210009
Not Yet Recruiting
6
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330006
Not Yet Recruiting
7
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
8
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
9
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
10
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310016
Not Yet Recruiting
Research Team
G
Global CORP Clinical Trials Disclosure
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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