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

This study has been completed.
Sponsor:
Collaborator:
Charite University, Berlin, Germany
Information provided by:
University of Regensburg
ClinicalTrials.gov Identifier:
NCT00538928
First received: October 2, 2007
Last updated: March 1, 2011
Last verified: March 2009
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by University of Regensburg:

Primary Outcome Measures:
  • Ventilator free days within 28 days after enrollment [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:

Responsible Party: Department of Anesthesia, University Hospital
ClinicalTrials.gov Identifier: NCT00538928     History of Changes
Other Study ID Numbers: KKS 4012-001-07
Study First Received: October 2, 2007
Last Updated: March 1, 2011
Health Authority: Germany: Koordinierungsstelle für klinische Studien (KKS) Charite Berlin

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

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

ClinicalTrials.gov processed this record on May 19, 2013