Correction by ECCO2-R of Hypercapnia in Patients With DVP in Moderate to Severe ARDS Under Protective Ventilation.

NCT03303807 | Completed

• 2 other identifiers: P1607012016-A01689-42
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary vascular dysfunction (DVP) is associated with a pejorative prognosis during ARDS. There is no specific therapeutic intervention to thwart it. Extracorporeal CO2 purification (ECCO2-R) is a technique that has been very rapidly diffused and adopted in intensive care since commercialization of the devices but, the formal clinical evaluation is insufficient. It could significantly improve the prognosis of patients with both DVP and refractory hypercapnia.

Conditions

Acute Respiratory Distress Syndrome; Hypercapnia

Keywords

Extracorporeal CO2 removal (ECCO2-R); ARDS

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with corrected hypercapnia

  20% decrease in PaCO2 two hours after ECCO2-R initiation

  at hour 2 (H2)

Secondary Outcomes (8)

• Relative change of capnia at H6 and H24 after ECCO2-R

  at hour 6 (H6), at hour 24 (H24)

• Proportion of patients with a decrease of at least 20% of PaCO2 to H6 and H24

  H6, H24

• Changes in echocardiographic indices

  H2, H6, H24

• Changes in hemodynamic parameters

  H2, H6, H24

• Changes in alveolar deadspace

  H2, H6, H24

Study Arms (1)

Extracorporeal CO2 removal

OTHER

Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)

Device: Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)

Interventions

Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter) DEVICE

A low-flow CO2 removal device (Prismalung®, Baxter) will be used with a conventional renal replacement therapy (RRT) platform (Prismaflex®, Baxter). In patients already treated with continuous RRT because of renal failure or metabolic acidosis, the HF 1400® (Baxter) set will be used to combine RRT and decarboxylation. Gas flow through the gas exchanger will be set up to 10 L/min, with an oxygen concentration from 0.21 to 1 and a blood flow of 200-400 mL/min. Patients will be ventilated with a target tidal volume of 6 ml/kg (predicted body weight) and a target plateau pressure below 30 cmH2O.

Extracorporeal CO2 removal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Moderate to severe ARDS according to the Berlin definition;
• Pulmonary vascular dysfunction at echocardiography (pulmonary arterial hypertension, right ventricular dilatation or dyskinesia of the interventricular septum);
• Refractory hypercapnia, defined by a PaCO2 ≥48 mmHg in spite of the reduction of the instrumental dead space and the increase of the respiratory rate.

You may not qualify if:

• Age \<18 years;
• Known pregnancy or breastfeeding;
• Contra-indication to curative anticoagulation, thrombocytopenia \<50 G / L, heparin-induced thrombocytopenia, known hypersensitivity to heparin or to compounds;
• Femoral or jugular venous access impossible;
• Refractory hypoxemia with indication at ECMO;
• No affiliation to social security or beneficiary

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Henri Mondor Hospital

Créteil, 94000, France

Location

Related Publications (1)

• Mekontso Dessap A, Bagate F, Repesse X, Blayau C, Fartoukh M, Canoui-Poitrine F, de Prost N, Vieillard-Baron A. Low-flow ECCO2R conjoined with renal replacement therapy platform to manage pulmonary vascular dysfunction with refractory hypercapnia in ARDS. Heliyon. 2023 Dec 19;10(1):e23878. doi: 10.1016/j.heliyon.2023.e23878. eCollection 2024 Jan 15.

  PMID: 38226285 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Armand Mekontso Dessap, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 6, 2017
• Study Start: January 10, 2018
• Primary Completion: February 25, 2019
• Study Completion: March 21, 2019
• Last Updated: July 5, 2019

Record last verified: 2018-09

Locations

FR (1)