Working… Menu
Help guide our efforts to modernize
Send us your comments by March 14, 2020.
Trial record 26 of 680 for:    CARBON DIOXIDE AND arterial

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01239966
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : February 23, 2016
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille

Brief Summary:

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 evaluate the safety and efficacy of adding a membranel oxygenator within an hemofiltration circuit, either upstream or downstream of the hemofilter.

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Intervention Details:
  • Device: Combined ECCOR and RRT
    Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.

Primary Outcome Measures :
  1. Arterial carbon dioxide reduction [ Time Frame: 20 min ]
    20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT

Secondary Outcome Measures :
  1. Gas transfer measurement [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of PO2 and PCO2 before and after the membrane oxygenation

  2. Arterial blood gases [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of arterial blood gases

  3. carbon dioxide elimination (VCO2) [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator

  4. Respiratory mechanics and hemodynamic parameters [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of respiratory mechanics and hemodynamic parameters

  5. Safety monitoring [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]

    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.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01239966

Layout table for location information
Hopital Paul Desbief
Marseille, France, 13002
Hopital Ambroise Pare
Marseille, France, 13006
Sponsors and Collaborators
Hôpital Européen Marseille
Layout table for investigator information
Principal Investigator: Jérôme Allardet-Servent, MD Hopital Ambroise Pare

Additional Information:
Publications of Results:
Other Publications:
Layout table for additonal information
Responsible Party: Jerome Allardet-Servent, MD, MD, MSc, Hôpital Européen Marseille Identifier: NCT01239966    
Other Study ID Numbers: 2010-A00397-32
First Posted: November 15, 2010    Key Record Dates
Last Update Posted: February 23, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Jerome Allardet-Servent, MD, Hôpital Européen Marseille:
Acute Respiratory Distress syndrome
Acute renal Failure
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Renal Insufficiency
Acute Kidney Injury
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Kidney Diseases
Urologic Diseases
Lung Injury