Clinical trial NCT01239966: Pulmonary And Renal Support During Acute Respiratory Distress Syndrome
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Respiratory Distress Syndrome
Acute Renal Failure
Keywords: Acute Respiratory Distress syndrome
Acute renal Failure
Lead sponsor: Hôpital Européen Marseille
Sponsor class: OTHER
First posted: 2010-11-15
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Arterial carbon dioxide reduction
timeFrame: 20 min
Secondary outcomes:
measure: Gas transfer measurement
timeFrame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
measure: Arterial blood gases
timeFrame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
measure: carbon dioxide elimination (VCO2)
timeFrame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
measure: Respiratory mechanics and hemodynamic parameters
timeFrame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
measure: Safety monitoring
timeFrame: 20 min, H1, H6, H12, H24, H36, H48 and H72.
Other outcomes:
Locations:
city: Marseille
country: France
facility: Hopital Paul Desbief
city: Marseille
country: France
facility: Hopital Ambroise Pare
Study officials:
affiliation: Hopital Ambroise Pare
name: Jérôme Allardet-Servent, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.