Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

NCT ID: NCT01239966

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2015-06-30

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.

Conditions

Acute Respiratory Distress Syndrome; Acute Renal Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Jerome Allardet-Servent, MD

MD, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jérôme Allardet-Servent, MD

Role: PRINCIPAL_INVESTIGATOR

Hopital Ambroise Pare

Locations

Hopital Paul Desbief

Marseille, , France

Hopital Ambroise Pare

Marseille, , France

Countries

France

References

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.

Reference Type: BACKGROUND

PMID: 17038660 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19741487 (View on PubMed)

Related Links

http://www.hopitaux-ambroisepare-desbief.com/

information related to hospitals and investigators involved

Other Identifiers

2010-A00397-32

Identifier Type: -

Identifier Source: org_study_id