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

November 12, 2010
May 18, 2014
November 2010
November 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01239966 on ClinicalTrials.gov Archive Site
  • 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.

Same as current
Not Provided
Not Provided
 
Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure

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.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Acute Respiratory Distress Syndrome
  • Acute Renal Failure
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 2015
November 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jérôme Allardet-Servent, MD 33491833867 j_allardet@ch-ambroisepare.fr
France
 
NCT01239966
2010-A00397-32
No
Jerome Allardet-Servent, MD, Hôpital Européen Marseille
Hôpital Européen Marseille
Not Provided
Principal Investigator: Jérôme Allardet-Servent, MD Hopital Ambroise Pare
Hôpital Européen Marseille
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP