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

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

Overview

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.

Interventions

• Device 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
• Other Invasive Mechanical Ventilation
  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

Primary outcome measures

• The percent decrease of partial pressure of carbon dioxide (PaCO2) from baseline after 2h of treatment. [Time frame: 2 hours after treatment]

Secondary outcome measures (12)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 10 centers

• China-Japan Friendship Hospital — Beijing
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou
• The University of Hong Kong-Shenzhen Hospital — Shenzhen
• The First Affiliated Hospital of Harbin Medical University — Harbin
• Zhongda Hospital Southeast University — Nanjing
• The First Affiliated Hospital of Nanchang University — Nanchang
• ZhongShan Hospital Fudan University — Shanghai
• Sichuan Provincial People's Hospital — Chengdu
• … and 2 more centers

Identifiers

NCT: NCT07326215 · BXU614243

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗