Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03004885
Other study ID # 2016-A01523-48
Secondary ID
Status Terminated
Phase N/A
First received December 14, 2016
Last updated March 10, 2018
Start date October 12, 2017
Est. completion date December 20, 2017

Study information

Verified date March 2018
Source Hôpital Européen Marseille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Acute Respiratory Distress Syndrome (ARDS) still remains associated with a mortality rate of 30 - 45 % despite improvement in mechanical ventilation. Driving pressure, defined as the difference between the end-inspiratory and the end-expiratory airway pressure, appears as an important factor contributing to mortality in patients with the ARDS. In patients already receiving a conventional tidal volume of 6 ml/kg predicted body weight (PBW), a driving pressure ≥ 14 cmH2O increases the risk of death in the hospital. One mean to lower the driving pressure is to decrease the tidal volume such that from 6 to 4 ml/kg predicted body weight. However, this strategy promotes hypercarbia by reducing the alveolar ventilation, providing the respiratory rate is constant. In this setting, implementing an extracorporeal CO2 removal (ECCO2R) therapy may offset the associated hypercarbia. The investigators have previously demonstrated that combining a membrane oxygenator within an hemofiltration circuit provides efficacious low flow ECCO2R on a renal replacement therapy monitor. In this study, we thought to investigate the efficacy of the PrismaLung stand-alone therapy. Using a PrismaFlex monitor and a HP-X circuit, a neonatal membrane oxygenator (PrismaLung) is used to provide decarboxylation without renal replacement therapy. The study will consist in three periods:

- The first period will address the efficacy of the PrismaLung device at tidal volume of 6 and 4 ml/kg PBW using an off-on-off design.

- The second part of the study will investigate the effect of varying the sweep gas flow and the mixture of the sweep gas on the CO2 removal rate (random order).

- The third part will compare three ventilatory strategies applied in a cross-over design :

1. Minimal distension: Tidal volume 4 ml/kg PBW and positive end-expiratory pressure (PEEP) based on the ARDSNet PEEP/FiO2 table (ARMA).

2. Maximal recruitment: 4 ml/kg PBW and PEEP adjusted to maintain a plateau pressure between 23 - 25 cmH2O.

3. Standard: Tidal volume 6 ml/kg and PEEP based on the ARDSNet PEEP/FiO2 table (ARMA).

Each strategies will be apply in a random order for a duration of 22 hours. Pulmonary inflammatory and fibrosis pathway will be assess before and after each period using bronchoalveolar lavage (BAL) samples. Systemic inflammatory cytokines will also be investigate. Main measurements will include respiratory mechanics, transpulmonary pressure, work of breathing, end-expiratory lung volume and tidal ventilation using electrical impedance tomography.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date December 20, 2017
Est. primary completion date October 13, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- ARDS moderate or severe (Berlin criteria)

- Onset < 48 h

- Driving pressure = 14 cmH2O

Exclusion Criteria:

- Lack of consent or social protection

- Chronic respiratory failure (requiring Oxygen or NIPPV)

- Severe hypoxemia: PaO2/FIO2 < 100 with PEEP = 18 cmH2O AND FIO2 = 1

- Acute Renal Failure requiring RRT

- DNR order or death expected within the next 72 hours

- Planned surgery or out-of-ICU transportation expected within the next 72 hours

- Heparin allergy

- Contraindication to jugular vein catheterization

- Intracranial Hypertension

Study Design


Related Conditions & MeSH terms

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

Intervention

Device:
PrismaLung
Low flow Extracorporeal CO2 removal using a 0.32 m² membrane oxygenator

Locations

Country Name City State
France Hopital Europeen Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

References & Publications (3)

Allardet-Servent J, Castanier M, Signouret T, Soundaravelou R, Lepidi A, Seghboyan JM. Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With Acute Respiratory Distress Syndrome and Acute Kidney Injury: T — View Citation

Amato MB, Meade MO, Slutsky AS, Brochard L, Costa EL, Schoenfeld DA, Stewart TE, Briel M, Talmor D, Mercat A, Richard JC, Carvalho CR, Brower RG. Driving pressure and survival in the acute respiratory distress syndrome. N Engl J Med. 2015 Feb 19;372(8):74 — View Citation

Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Plasma Free Hemoglobin q24 h, up to 72 h
Other Haptoglobin q24 h, up to 72 h
Other Lacticodéshydrogenase (LDH) q24 h, up to 72 h
Other schizocytes q24 h, up to 72 h
Other Bilirubin q24 h, up to 72 h
Primary Change in PaCO2 20 % decrease in PaCO2 after initiation of ECCO2R (PrismaLung) at tidal volume of 4 ml/kg PBW versus 4 ml/kg PBW without ECCO2R. 15 min after initiation of ECCO2R (PrismaLung) at tidal volume of 4 ml/kg PBW (during the first part of the study).
Secondary PaCO2 Arterial blood gas q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary CO2 removal rate Using both the blood side and the gas side equation q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Respiratory mechanics work of breathing Using oesophageal ballon (NutriVent catheter) and FluxMed monitor (MBMed) q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Transpulmonary pressure Using oesophageal ballon (NutriVent catheter) and FluxMed monitor (MBMed) q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Work of breathing Using oesophageal ballon (NutriVent catheter) and FluxMed monitor (MBMed) q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary EIT Electrical Impedance Tomography using BB² (Swisstom) q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary EELV End expiratory Lung volume using nitrogen wash-in wash-out method (Engstrom GE) q15 min during part 1 and part 2 of the study. In the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Plasma Cytokines Elisa using plasma samples Only in the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Pulmonary Cytokines Elisa using BAL samples Only in the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Pulmonary Type III Procollagen RIA using plasma and BAL samples Only in the third part, measurement at baseline, 1 hour and 22 hours in each arm.
Secondary Pulmonary Inflammatory and Fibrotic pathway mRNA Only in the third part, measurement at baseline, 1 hour and 22 hours in each arm.
See also
  Status Clinical Trial Phase
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Recruiting NCT05535543 - Change in the Phase III Slope of the Volumetric Capnography by Prone Positioning in Acute Respiratory Distress Syndrome
Completed NCT04695392 - Restore Resilience in Critically Ill Children N/A
Terminated NCT04972318 - Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia N/A
Completed NCT04534569 - Expert Panel Statement for the Respiratory Management of COVID-19 Related Acute Respiratory Failure (C-ARF)
Completed NCT04078984 - Driving Pressure as a Predictor of Mechanical Ventilation Weaning Time on Post-ARDS Patients in Pressure Support Ventilation.
Completed NCT04451291 - Study of Decidual Stromal Cells to Treat COVID-19 Respiratory Failure N/A
Not yet recruiting NCT06254313 - The Role of Cxcr4Hi neutrOPhils in InflueNza
Not yet recruiting NCT04798716 - The Use of Exosomes for the Treatment of Acute Respiratory Distress Syndrome or Novel Coronavirus Pneumonia Caused by COVID-19 Phase 1/Phase 2
Withdrawn NCT04909879 - Study of Allogeneic Adipose-Derived Mesenchymal Stem Cells for Non-COVID-19 Acute Respiratory Distress Syndrome Phase 2
Terminated NCT02867228 - Noninvasive Estimation of Work of Breathing N/A
Not yet recruiting NCT02881385 - Effects on Respiratory Patterns and Patient-ventilator Synchrony Using Pressure Support Ventilation N/A
Completed NCT02545621 - A Role for RAGE/TXNIP/Inflammasome Axis in Alveolar Macrophage Activation During ARDS (RIAMA): a Proof-of-concept Clinical Study
Withdrawn NCT02253667 - Palliative Use of High-flow Oxygen Nasal Cannula in End-of-life Lung Disease Patients N/A
Completed NCT02232841 - Electrical Impedance Imaging of Patients on Mechanical Ventilation N/A
Completed NCT02889770 - Dead Space Monitoring With Volumetric Capnography in ARDS Patients N/A
Completed NCT01504893 - Very Low Tidal Volume vs Conventional Ventilatory Strategy for One-lung Ventilation in Thoracic Anesthesia N/A
Withdrawn NCT01927237 - Pulmonary Vascular Effects of Respiratory Rate & Carbon Dioxide N/A
Completed NCT02814994 - Respiratory System Compliance Guided VT in Moderate to Severe ARDS Patients N/A
Completed NCT01680783 - Non-Invasive Ventilation Via a Helmet Device for Patients Respiratory Failure N/A