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Trial record 33 of 861 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.
 
ClinicalTrials.gov Identifier: NCT01239966
Recruitment Status : Completed
First Posted : November 15, 2010
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
Jerome Allardet-Servent, MD, Hôpital Européen Marseille

Tracking Information
First Submitted Date  ICMJE November 12, 2010
First Posted Date  ICMJE November 15, 2010
Last Update Posted Date February 23, 2016
Study Start Date  ICMJE November 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
Arterial carbon dioxide reduction [ Time Frame: 20 min ]
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 12, 2010)
  • 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
  • Arterial blood gases [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of arterial blood gases
  • 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
  • Respiratory mechanics and hemodynamic parameters [ Time Frame: 20 min, H1, H6, H12, H24, H36, H48 and H72. ]
    Measurement of respiratory mechanics and hemodynamic parameters
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
Official Title  ICMJE Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Acute Respiratory Distress Syndrome
  • Acute Renal Failure
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 24, 2015)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 12, 2010)
10
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01239966
Other Study ID Numbers  ICMJE 2010-A00397-32
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Jerome Allardet-Servent, MD, Hôpital Européen Marseille
Study Sponsor  ICMJE Hôpital Européen Marseille
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jérôme Allardet-Servent, MD Hopital Ambroise Pare
PRS Account Hôpital Européen Marseille
Verification Date February 2016

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