Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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
- 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: | October 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
-
Device: Combined ECCOR and RRT
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Jérôme Allardet-Servent, MD | 33491833867 | j_allardet@ch-ambroisepare.fr |
| 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 | |
| Principal Investigator: | Jérôme Allardet-Servent, MD | Hopital Ambroise Pare |
More Information
Additional Information:
Publications:
| Responsible Party: | Jerome Allardet-Servent, MD, MSc, Hôpital Ambroise Paré |
| ClinicalTrials.gov Identifier: | NCT01239966 History of Changes |
| Other Study ID Numbers: | 2010-A00397-32 |
| Study First Received: | November 12, 2010 |
| Last Updated: | December 4, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Hôpital Ambroise Paré:
|
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 May 23, 2013