Mild to Moderate Acute Respiratory Distress Syndrome
Conditions
Brief summary
PrismaLung+ is intended to provide extracorporeal carbon dioxide removal (ECCO2R) as a standalone therapy or in combination with continuous renal replacement therapy (CRRT). This study is a multi-centre, prospective, open-label, single-arm study. Adult patients with mild or moderate acute respiratory distress syndrome (ARDS) requiring mechanical ventilation were planned to receive ultra-lung protective ventilation (ULPV) associated with ECCO2R using PrismaLung+. The study will assess the capability of PrismaLung+ to allow ULPV, defined as a tidal volume (VT) of 4 mL/kg of predicted body weight, and confirm the safety of PrismaLung+.
Interventions
DEVICEPrismaLung+
Overall, up to 60 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as standalone therapy and another minimum of approximately 15 patients will receive ECCO2R using PrismaLung+ in combination with CRRT.
Sponsors
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age is ≥ 18 years old 2. Patient is expected to receive ECCO2R for a minimum of 24 hours 3. Patient has mild or moderate ARDS according to the Berlin definition: * 100 mm Hg \< PaO2/FiO2 ≤ 300 mm Hg, with PEEP ≥ 5 cm H2O, and * Bilateral lung opacities not fully explained by effusions, lobar/lung collapse, or nodules, and * Respiratory failure not fully explained by cardiac failure or fluid overload 4. Written informed consent to participate in the study from the patient, if possible, or from the identified authorized representative if the patient is unable to provide consent.
Exclusion criteria
1. Patients body weight \< 30 kg 2. Patients with a contraindication for systemic anticoagulation with heparin 3. Patients with a platelet count \< 50,000/µL 4. Patients on MV \> 7 days 5. Patients with very severe, or stage 4 (as per GOLD staging System) chronic obstructive pulmonary disease (COPD) 6. Current or history of heparin-induced thrombocytopenia 7. Patients who are pregnant and/or breastfeeding 8. Patients not expected to survive the duration of the planned study treatment period (24 hours) 9. Patients currently participating in another interventional clinical study, except if the patient is in an investigational medicinal product study, already in follow-up without further administration of study drug, and has not received any investigational medicinal product within 5 half-lives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events related to study procedure | Day 1 to Day 28 | Adverse events related to the study procedure (ECCO2R or ECCO2R in combination with CRRT), irrespective of relatedness to the device. |
| Number of participants achieving ultra-lung protective ventilation (ULPV) 8 and 24 hours following ECCO2R initiation | 8 and 24 hours following ECCO2R initiation | Must maintain PaCO2 \< 50 mmHg. ULPV is defined as defined as a tidal volume (VT) of 4 mL/kg of predicted body weight. |
| Adverse Events related to study device | Day 1 to Day 28 | Adverse event related to the use of a study device. This definition includes AEs resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction of the study device. This definition includes any event resulting from use error or from intentional misuse of the study device. |
| Adverse events of special interest (AESIs) | Day 1 to Day 28 | The AESI's for this study include significant bleeding events (i.e. require administration of ≥ 1 unit of packed red blood cells (pRBC) or result in a related SAE). |
| Adverse Device Effect (ADE) | Day 1 to Day 28 | This includes study device and study procedure related adverse events. |
| Adverse Events leading to study withdrawal | Day 1 to Day 28 | Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in patients, users or other persons, in the context of a clinical investigation leading to study withdrawal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbon dioxide clearance after ECCO2R treatment | 8 hours following ECCO2R initiation | CO2 clearance (mL/min) will be summarized descriptively by group and in total |
Countries
France
Outcome results
None listed