Extrapulmonary Interventional Ventilatory Support in Severe ARDS - Full Text View

Sponsored by:	University of Regensburg
Information provided by:	University of Regensburg
ClinicalTrials.gov Identifier:	NCT00538928

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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 ]

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
Estimated Study Completion Date:	August 2009

Arms	Assigned Interventions
1: Experimental 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
2: Active Comparator 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

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

Contacts

Contact: Thomas Bein, Professor	++49-941-944-0	thomas.bein@klinik.uni-regensburg.de
Contact: Markus Zimmermann, Dr.	++49-941-944-0	markus.zimmermann@klinik.uni-regensburg.de

Locations

Germany
University Hospital Regensburg	Recruiting
Regensburg, Germany, 93042
Contact: Thomas Bein, Professor ++49-941-944-0 thomas.bein@klinik.uni-regensburg.de
Contact: Steffen Weber-Carstens, Dr. ++49-30-450-651055 steffen.weber-carstens@charite.de

Sponsors and Collaborators

University of Regensburg

Investigators

Principal Investigator:	Thomas Bein, Professor Dr.	University Hospital Regensburg
Study Chair:	Steffen Weber-Carstens, Dr.	Charite University Hospital Berlin

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.

Study ID Numbers:	KKS 4012-001-07
Study First Received:	October 2, 2007
Last Updated:	October 2, 2007
ClinicalTrials.gov Identifier:	NCT00538928
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)

Study placed in the following topic categories:

Respiratory Tract Diseases
Hypercapnia
Lung Diseases

Respiration Disorders
Respiratory Distress Syndrome, Adult
Acute respiratory distress syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome

ClinicalTrials.gov processed this record on February 06, 2009