Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS) - Full Text View

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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Heinz Body Anemias Respiratory Distress Syndrome, Infant

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

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.

Additional 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
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:


Acute Lung Injury Respiratory Distress Syndrome, Adult Respiratory Distress Syndrome, Newborn Infant, Newborn, Diseases Infant, Premature, Diseases	Lung Diseases Lung Injury Respiration Disorders Respiratory Tract Diseases

ClinicalTrials.gov processed this record on March 03, 2015

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