Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

Phase 3

Completed

• Conditions: Acute Renal Failure; Acute Respiratory Distress Syndrome

• Registration Number: NCT01239966
• Lead Sponsor: Hôpital Européen Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2010-11-12
• Study First Submitted QC: 2010-11-12
• Study First Posted: 2010-11-15
• Primary Completion: 2014-12
• Study Completion: 2015-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-21
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Arterial carbon dioxide reduction	20 min	20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT

Secondary Outcome Measures

Name	Time	Method
Gas transfer measurement	20 min, H1, H6, H12, H24, H36, H48 and H72.	Measurement of PO2 and PCO2 before and after the membrane oxygenation
Safety monitoring	20 min, H1, H6, H12, H24, H36, H48 and H72.	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.
Arterial blood gases	20 min, H1, H6, H12, H24, H36, H48 and H72.	Measurement of arterial blood gases
carbon dioxide elimination (VCO2)	20 min, H1, H6, H12, H24, H36, H48 and H72.	Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator
Respiratory mechanics and hemodynamic parameters	20 min, H1, H6, H12, H24, H36, H48 and H72.	Measurement of respiratory mechanics and hemodynamic parameters

Trial Locations

Locations (2)

Hopital Paul Desbief; 🇫🇷 Marseille, France

Hopital Ambroise Pare; 🇫🇷 Marseille, France