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

Safety and Efficacy of Combined Extracorporeal CO2 Removal and Renal Replacement Therapy in Patients With the Acute Respiratory Distress Syndrome and Acute Renal Failure

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.

Study Overview

• Status: Completed
• Conditions: Acute Renal Failure; Acute Respiratory Distress Syndrome
• Intervention / Treatment: Device: Combined ECCOR and RRT

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Marseille, France, 13002
    • Hopital Paul Desbief
  • Marseille, France, 13006
    • Hôpital Ambroise Paré

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial carbon dioxide reduction	20 % reduction of arterial carbon dioxide tension after 20 min of combined ECCOR and RRT	20 min

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hôpital Européen Marseille
• Investigators: Principal Investigator: Jérôme Allardet-Servent, MD, Hôpital Ambroise Paré

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• information related to hospitals and investigators involved

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: November 12, 2010
• First Submitted That Met QC Criteria: November 12, 2010
• First Posted (Estimate): November 15, 2010

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: February 21, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: Acute Respiratory Distress syndrome; Acute renal Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Kidney Diseases; Urologic Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Syndrome; Renal Insufficiency; Acute Kidney Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 2010-A00397-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO