Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)
Primary Purpose
Acute Respiratory Distress Syndrome, Acute Renal Failure
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Combined ECCOR and RRT
Sponsored by
About this trial
This is an interventional supportive care trial for Acute Respiratory Distress Syndrome focused on measuring Acute Respiratory Distress syndrome, Acute renal Failure
Eligibility 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
Sites / Locations
- Hopital Paul Desbief
- Hopital Ambroise Pare
Outcomes
Primary Outcome Measures
Arterial carbon dioxide reduction
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
Secondary Outcome Measures
Gas transfer measurement
Measurement of PO2 and PCO2 before and after the membrane oxygenation
Arterial blood gases
Measurement of arterial blood gases
carbon dioxide elimination (VCO2)
Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
Respiratory mechanics and hemodynamic parameters
Measurement of respiratory mechanics and hemodynamic parameters
Safety monitoring
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.
Full Information
NCT ID
NCT01239966
First Posted
November 12, 2010
Last Updated
February 21, 2016
Sponsor
Hôpital Européen Marseille
1. Study Identification
Unique Protocol Identification Number
NCT01239966
Brief Title
Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
Acronym
PARSA
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 Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hôpital Européen Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Acute Renal Failure
Keywords
Acute Respiratory Distress syndrome, Acute renal Failure
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Combined ECCOR and RRT
Intervention Description
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 Measure Information:
Title
Arterial carbon dioxide reduction
Description
20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT
Time Frame
20 min
Secondary Outcome Measure Information:
Title
Gas transfer measurement
Description
Measurement of PO2 and PCO2 before and after the membrane oxygenation
Time Frame
20 min, H1, H6, H12, H24, H36, H48 and H72.
Title
Arterial blood gases
Description
Measurement of arterial blood gases
Time Frame
20 min, H1, H6, H12, H24, H36, H48 and H72.
Title
carbon dioxide elimination (VCO2)
Description
Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
Time Frame
20 min, H1, H6, H12, H24, H36, H48 and H72.
Title
Respiratory mechanics and hemodynamic parameters
Description
Measurement of respiratory mechanics and hemodynamic parameters
Time Frame
20 min, H1, H6, H12, H24, H36, H48 and H72.
Title
Safety monitoring
Description
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.
Time Frame
20 min, H1, H6, H12, H24, H36, H48 and H72.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jérôme Allardet-Servent, MD
Organizational Affiliation
Hopital Ambroise Pare
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Paul Desbief
City
Marseille
ZIP/Postal Code
13002
Country
France
Facility Name
Hopital Ambroise Pare
City
Marseille
ZIP/Postal Code
13006
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
17038660
Citation
Terragni PP, Rosboch G, Tealdi A, Corno E, Menaldo E, Davini O, Gandini G, Herrmann P, Mascia L, Quintel M, Slutsky AS, Gattinoni L, Ranieri VM. Tidal hyperinflation during low tidal volume ventilation in acute respiratory distress syndrome. Am J Respir Crit Care Med. 2007 Jan 15;175(2):160-6. doi: 10.1164/rccm.200607-915OC. Epub 2006 Oct 12.
Results Reference
background
PubMed Identifier
19741487
Citation
Terragni PP, Del Sorbo L, Mascia L, Urbino R, Martin EL, Birocco A, Faggiano C, Quintel M, Gattinoni L, Ranieri VM. Tidal volume lower than 6 ml/kg enhances lung protection: role of extracorporeal carbon dioxide removal. Anesthesiology. 2009 Oct;111(4):826-35. doi: 10.1097/ALN.0b013e3181b764d2.
Results Reference
result
Links:
URL
http://www.hopitaux-ambroisepare-desbief.com/
Description
information related to hospitals and investigators involved
Learn more about this trial
Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
We'll reach out to this number within 24 hrs