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Pulmonary And Renal Support During Acute Respiratory Distress Syndrome (PARSA)

H

Hôpital Européen Marseille

Status and phase

Completed
Phase 3

Conditions

Acute Respiratory Distress Syndrome
Acute Renal Failure

Treatments

Device: Combined ECCOR and RRT

Study type

Interventional

Funder types

Other

Identifiers

NCT01239966
2010-A00397-32

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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