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Completed

NCT Number: NCT01239966

Pulmonary And Renal Support During Acute Respiratory Distress Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hopital Ambroise Pare, Marseille, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combined ECCOR and RRT

Device

Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.

Primary outcomes

  1. Arterial carbon dioxide reduction

    Time frame: 20 min

    20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT

Secondary outcomes

  1. Gas transfer measurement

    Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.

    Measurement of PO2 and PCO2 before and after the membrane oxygenation

  2. Arterial blood gases

    Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.

    Measurement of arterial blood gases

  3. carbon dioxide elimination (VCO2)

    Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.

    Measurement of carbon dioxide elimination rate at the ventilator and at the membrane oxygenator

  4. Respiratory mechanics and hemodynamic parameters

    Time frame: 20 min, H1, H6, H12, H24, H36, H48 and H72.

    Measurement of respiratory mechanics and hemodynamic parameters

  5. Safety monitoring

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille

Other

Registry information

Official study 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

Acronym: PARSA

Important dates

Study start
2010
Primary completion
2014
Study completion
2015
First posted
Nov 15, 2010
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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