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Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS) (Xtravent)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00538928
First Posted: October 3, 2007
Last Update Posted: March 2, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Charite University, Berlin, Germany
Information provided by:
University of Regensburg
  Purpose
A prospective, randomized study will be performed investigating the effects of a pumpless extracorporeal interventional lung assist [iLA] on the implementation of a lung-protective ventilatory strategy in patients with acute respiratory distress syndrome [ARDS] with a PaO2/FiO2 ratio < 200. The duration of ventilation, intensive care and hospital stay and in-hospital mortality will be investigated.

Condition Intervention
Acute Respiratory Distress Syndrome Other: lung protective ventilation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study

Resource links provided by NLM:


Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Ventilator free days within 28 days after enrollment [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • hospital mortality, organ-failure free days, pulmonary gas exchange [ Time Frame: 28 days - 60 days ]

Estimated Enrollment: 120
Study Start Date: September 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Intervention: Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.
Other: lung protective ventilation
tidal volume 6 ml/kg ideal body weight
Active Comparator: 2
no device: Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).
Other: lung protective ventilation
tidal volume 6 ml/kg ideal body weight

Detailed Description:

Evaluation group:

Implantation of the iLA - adaptation of the ventilation strategy, explantation of the iLA after corresponding improvement (see treatment plan for details) - weaning from the ventilation and extubation according to specified criteria.

Control group:

Ventilation strategy based on the concept of lung-protective ventilation without extracorporeal support, weaning from the ventilation and extubation according to specified criteria (see treatment plan for details).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The trial subjects are patients aged 18 years or older who have developed severe ARDS. Following the American-European Consensus Conference on ARDS, severe ARDS is defined as an oxygenation index (PaO2/FIO2) < 200 mmHg. These parameters must be present for a duration of at least 2 hours.

Exclusion Criteria:

  • age < 18 years
  • decompensated heart insufficiency
  • acute coronary syndrome
  • severe chronic obstructive pulmonary disease
  • advanced tumour conditions with life expectancy < 6 months
  • chronic dialysis treatment
  • lung transplant patients
  • proven Heparin-induced thrombocytopenia (HIT)
  • morbid obesity (BMI >) 40
  • Child Class B and C cirrhosis of the liver, acute fulminant hepatic failure
  • severe peripheral arterial occlusive disease (pAVK III - IV), absence of limb doppler pulse
  • brain injury (GCS < 9 + CT pathology)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538928


Locations
Germany
University Hospital Regensburg
Regensburg, Germany, 93042
Sponsors and Collaborators
University of Regensburg
Charite University, Berlin, Germany
Investigators
Principal Investigator: Thomas Bein, Professor Dr. University Hospital Regensburg
Study Chair: Steffen Weber-Carstens, Dr. Charite University Hospital Berlin
Study Chair: Thomas Staudinger, Prof University Hospital Vienna, Austria
Study Chair: Sven Bercker, MD University Hospital Leipzig, Germany
Study Chair: Ralph Müllenbach, MD PhD University Hospital Würzburg, Germany
Study Chair: Rolf Dembinski, MD PhD University Hospital Aachen, Germany
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Department of Anesthesia, University Hospital
ClinicalTrials.gov Identifier: NCT00538928     History of Changes
Other Study ID Numbers: KKS 4012-001-07
First Submitted: October 2, 2007
First Posted: October 3, 2007
Last Update Posted: March 2, 2011
Last Verified: March 2009

Keywords provided by University of Regensburg:
acute respiratory distress syndrome
extracorporeal lung support
hypoxia
hypercapnia
acute respiratory distress syndrome (ARDS)

Additional relevant MeSH terms:
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury