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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Acute Respiratory Distress Syndrome	Other: lung protective ventilation	Not Applicable

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	January 2011
Actual Study Completion Date :	January 2011

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Bein T, Weber F, Philipp A, Prasser C, Pfeifer M, Schmid FX, Butz B, Birnbaum D, Taeger K, Schlitt HJ. A new pumpless extracorporeal interventional lung assist in critical hypoxemia/hypercapnia. Crit Care Med. 2006 May;34(5):1372-7.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bein T, Weber-Carstens S, Goldmann A, Müller T, Staudinger T, Brederlau J, Muellenbach R, Dembinski R, Graf BM, Wewalka M, Philipp A, Wernecke KD, Lubnow M, Slutsky AS. Lower tidal volume strategy (≈3 ml/kg) combined with extracorporeal CO2 removal versus 'conventional' protective ventilation (6 ml/kg) in severe ARDS: the prospective randomized Xtravent-study. Intensive Care Med. 2013 May;39(5):847-56. doi: 10.1007/s00134-012-2787-6. Epub 2013 Jan 10.

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
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