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

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ClinicalTrials.gov Identifier: NCT00538928
Recruitment Status : Completed
First Posted : October 3, 2007
Last Update Posted : March 2, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Acute Respiratory Distress Syndrome Other: lung protective ventilation

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).


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
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
Study Start Date : September 2007
Primary Completion Date : January 2011
Study Completion Date : January 2011


Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

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 Posted: October 3, 2007    Key Record Dates
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