Low-Flow CO2 Removal for Mild to Moderate ARDS With PRISMALUNG

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Extracorporeal CO2 Removal (ECCO2R) With a Renal Replacement Platform (PRISMALUNG) to Enhance Lung Protective Ventilation in Patients With Mild to Moderate Acute Respiratory Distress Syndrome (ARDS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02606240
• Other study ID #: PSL-AC-11-11-15
• Status: Completed
• Phase: N/A
• First received: November 11, 2015
• Last updated: August 5, 2017
• Start date: March 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Groupe Hospitalier Pitie-Salpetriere
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of Extracorporeal CO2 removal (ECCO2R) following tidal volume (Vt), and plateau pressure reduction in patients with mild to moderate ARDS.

Description:

Extracorporeal CO2 removal (ECCO2R) with a low-flow CO2 removal device (Prismalung, Gambro-Baxter) integrated on the Prismaflex platform (Gambro-Baxter) allows tidal volume (Vt) and plateau pressure reduction in patients with mild to moderate ARDS. This pilot observational study will assess changes in pH /PaO2 /PaCO2, Respiratory Rate and device CO2 clearance in the first 24 hours of ECCO2R following Vt and plateau pressure reduction in patients with mild to moderate ARDS. Safety variables during treatment will also be analyzed. A series of 20 consecutive patients will be included in this observational study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mechanical ventilation with expected duration of >24 hours

• Mild to moderate Acute Respiratory Distress Syndrome (ARDS) according to the Berlin definition: 100 mmHg <PaO2/FiO2 <300 mmHg, with PEEP > 5 cmH2O

Exclusion Criteria:

• Age <18 years

• Pregnancy

• Severe hypoxemia with PaO2/FiO2 <100 mmHg

• Body mass index > 40 kg/m2

• Decompensated heart insufficiency or acute coronary syndrome

• Severe Chronic obstructive pulmonary disease (COPD)

• Major respiratory acidosis with PaCO2 >60 mmHg

• Acute brain injury

• Severe liver insufficiency (Child-Pugh scores >7) or fulminant hepatic failure

• Heparin-induced thrombocytopenia

• Contraindication for systemic anticoagulation

• Patient moribund, decision to limit therapeutic interventions

• Catheter access to femoral vein or jugular vein impossible

• Pneumothorax

• Platelet <50 G/L

• Lacking consent

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Device:
• CO2 removal with PRISMALUNG in ARDS
Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.

Locations

Country	Name	City	State
France	CHU AMIENS, Département Anesthésie Réanimation	Amiens
France	CHU Besançon, Réanimation	Besançon
France	CHU CLERMONT FERRAND, Département Anesthésie Réanimation	Clermont Ferrand
France	CHU MONTPELLIER, Département Anesthésie Réanimation	Montpellier
France	Hopital Pitié Salpetriere, Reanimation Medicale	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Groupe Hospitalier Pitie-Salpetriere	Centre Hospitalier Universitaire de Besancon, Centre Hospitalier Universitaire, Amiens, University Hospital, Clermont-Ferrand, University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.	Number of participants who achieved a tidal volume (Vt) reduction to 4 mL/kg while maintaining pH and PaCO2 to ± 20% of baseline values obtained at Vt of 6 mL/kg.	24 hours
Secondary	Assessment of changes in Vt	Assessment of changes in Vt	24 hours
Secondary	Assessment of changes in Plateau Pressure	Assessment of changes in Plateau Pressure	24 hours
Secondary	Assessment of changes in respiratory rate	Assessment of changes in respiratory rate	24 hours
Secondary	Assessment of changes in Positive End-Expiratory Pressure, PEEP	Assessment of changes in Positive End-Expiratory Pressure, PEEP	24 hours
Secondary	Change in vasopressor use	Epineprine and norepinephine dose, mcg/kg/min	24 hours
Secondary	Evaluation of lung recruitment/derecruitment	With lung echography. Ccording to the method described by Bouhemad et al, Am J Respir Crit Care Med. 2011 Feb 1;183(3):341-7	24 hours
Secondary	Lifetime of the extracorporeal circulation	In hours	7 days
Secondary	Number of participants with adverse events directly related to ECCO2R	Adverse events directly related to ECCO2R are hemolysis (serum free hemoglobin >500 mg/L), infection at the cannulation site, Hemorrhage at the cannulation site, air entry in the circuit.	7 days