Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

Acute Respiratory Distress Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239966
• Other study ID #: 2010-A00397-32
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2010
• Last updated: February 21, 2016
• Start date: November 2010
• Est. completion date: June 2015

Study information

• Verified date: February 2016
• Source: Hôpital Européen Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: June 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Lung Injury
• Acute Renal Failure
• Acute Respiratory Distress Syndrome
• Renal Insufficiency
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Ambroise Pare	Marseille
France	Hopital Paul Desbief	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Européen Marseille

Country where clinical trial is conducted

France, 

References & Publications (2)

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):82 — View 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. Epub 2006 Oct 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial carbon dioxide reduction	20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT	20 min	No
Secondary	Gas transfer measurement	Measurement of PO2 and PCO2 before and after the membrane oxygenation	20 min, H1, H6, H12, H24, H36, H48 and H72.	No
Secondary	Arterial blood gases	Measurement of arterial blood gases	20 min, H1, H6, H12, H24, H36, H48 and H72.	No
Secondary	carbon dioxide elimination (VCO2)	Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator	20 min, H1, H6, H12, H24, H36, H48 and H72.	No
Secondary	Respiratory mechanics and hemodynamic parameters	Measurement of respiratory mechanics and hemodynamic parameters	20 min, H1, H6, H12, H24, H36, H48 and H72.	No
Secondary	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.	20 min, H1, H6, H12, H24, H36, H48 and H72.	Yes

External Links

•   information related to hospitals and investigators involved