NCT01239966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2010

Longer than P75 for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

February 23, 2016

Status Verified

February 1, 2016

Enrollment Period

4.1 years

First QC Date

November 12, 2010

Last Update Submit

February 21, 2016

Conditions

Acute Respiratory Distress SyndromeAcute Renal Failure

Keywords

Acute Respiratory Distress syndromeAcute renal Failure

Outcome Measures

Primary Outcomes (1)

  • Arterial carbon dioxide reduction

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

    20 min

Secondary Outcomes (5)

  • Gas transfer measurement

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

  • Arterial blood gases

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

  • carbon dioxide elimination (VCO2)

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

  • Respiratory mechanics and hemodynamic parameters

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

  • Safety monitoring

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

Interventions

Combined ECCOR and RRTDEVICE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Acute Respiratory Distress Syndrome according to the AECC definition
  • Acute Renal Failure according to the RIFLE definition

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hopital Paul Desbief

Marseille, 13002, France

Location

Hopital Ambroise Pare

Marseille, 13006, France

Location

Related Publications (2)

  • 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.

    PMID: 17038660BACKGROUND

  • 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.

    PMID: 19741487RESULT

Related Links

MeSH Terms

Conditions

Respiratory Distress SyndromeAcute Kidney Injury

Interventions

Renal Replacement Therapy

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Jérôme Allardet-Servent, MD

    Hopital Ambroise Pare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, MSc

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 15, 2010

Study Start

November 1, 2010

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

February 23, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)