Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Hôpital Européen Marseille
Sponsor:
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille
ClinicalTrials.gov Identifier:
NCT01239966
First received: November 12, 2010
Last updated: May 18, 2014
Last verified: May 2014
  Purpose

In patients presenting with the acute respiratory distress syndrome (ARDS), mechanical ventilation with low tidal volume (6 ml/kg predicted body weight) is the current gold standard for supportive care. However, despite a relative low tidal volume, approximatively one third of patients will experienced tidal hyperinflation, a phenomenon known to induce pulmonary and systemic inflammatory response. A further reduction of the tidal volume to 4 ml/kg (PBW) will prevent pulmonary area from tidal hyperinflation. As a result, hypercarbia and respiratory acidosis are commonly observed with such very low tidal ventilation. Extra corporeal CO2 removal is one of a mean to normalize arterial CO2 tension.

Patients with ARDS also frequently develop acute renal failure which may required Renal Replacement Therapy. Some data suggests that starting early the RRT may favor outcome.

The investigators hypothesized that a strategy combining ECCOR and RRT early in the course of patients presenting ARDS and acute renal failure will allow the tidal volume to be further reduced, providing lung protection, while avoiding the arterial CO2 tension to be increased.

For this purpose, the investigators sought to investigate the safety and the efficacy of adding a neonatal oxygenator membrane within an hemofiltration circuit.


Condition Intervention Phase
Acute Respiratory Distress Syndrome
Acute Renal Failure
Device: Combined ECCOR and RRT
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure

Resource links provided by NLM:


Further study details as provided by Hôpital Européen Marseille:

Primary Outcome Measures:
  • Arterial carbon dioxide reduction [ Time Frame: 20 min ] [ Designated as safety issue: No ]
    20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT


Secondary Outcome Measures:
  • Gas transfer measurement [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ] [ Designated as safety issue: No ]
    Measurement of PO2 and PCO2 before and after the membrane oxygenation

  • Arterial blood gases [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ] [ Designated as safety issue: No ]
    Measurement of arterial blood gases

  • carbon dioxide elimination (VCO2) [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ] [ Designated as safety issue: No ]
    Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator

  • Respiratory mechanics and hemodynamic parameters [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ] [ Designated as safety issue: No ]
    Measurement of respiratory mechanics and hemodynamic parameters

  • Safety monitoring [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ] [ Designated as safety issue: Yes ]

    Continuous measurement of the differential pressure across the oxygenator membrane and across the hemofilter.

    Assessment of catheter dysfunction, clotting or disruption of the extra-corporeal circuit, clotting of the oxygenator membrane or of the hemofilter.

    Assessment of patient's haemorragic or thrombotic complications.



Estimated Enrollment: 10
Study Start Date: November 2010
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Combined ECCOR and RRT
    Insertion of a neonatal oxygenator membrane (Hilite 800 LT, Medos, Germany) within an hemofilter circuit (MultiFiltrate Kit 7 CVVH 1000,Fresenius Medical Care, Germany)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Acute Respiratory Distress Syndrome according to the AECC definition
  • Acute Renal Failure according to the RIFLE definition

Exclusion Criteria:

  • Age < 18 years
  • PaO2/FiO2 < 100 with FIO2 = 1 and PEEP > 18 cmH2O
  • DNR order or death expected within the next 3 days
  • Intracranial haemorrhage or hypertension
  • Heparin allergy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239966

Contacts
Contact: Jérôme Allardet-Servent, MD 33491833867 j_allardet@ch-ambroisepare.fr

Locations
France
Hopital Ambroise Pare Recruiting
Marseille, France, 13006
Contact: Jérôme Allardet-Servent, MD         
Principal Investigator: Jérôme Allardet-Servent, MD         
Sub-Investigator: Thomas Signouret, MD         
Hopital Paul Desbief Recruiting
Marseille, France, 13002
Contact: Jérôme Allardet-Servent, MD         
Principal Investigator: Jérôme Allardet-Servent, MD         
Sub-Investigator: Jean-Marie Seghboyan, MD         
Sponsors and Collaborators
Hôpital Européen Marseille
Investigators
Principal Investigator: Jérôme Allardet-Servent, MD Hopital Ambroise Pare
  More Information

Additional Information:
Publications:
Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille
ClinicalTrials.gov Identifier: NCT01239966     History of Changes
Other Study ID Numbers: 2010-A00397-32
Study First Received: November 12, 2010
Last Updated: May 18, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Hôpital Européen Marseille:
Acute Respiratory Distress syndrome
Acute renal Failure

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Kidney Diseases
Urologic Diseases
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury

ClinicalTrials.gov processed this record on July 29, 2014