Clinical trial NCT00538928: Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS)
Official title: Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Keywords: acute respiratory distress syndrome
extracorporeal lung support
hypoxia
hypercapnia
acute respiratory distress syndrome (ARDS)
Lead sponsor: University of Regensburg
Sponsor class: OTHER
Collaborators: name: Charite University, Berlin, Germany
First posted: 2007-10-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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)

Primary outcomes:
measure: Ventilator free days within 28 days after enrollment
timeFrame: 28 days
Secondary outcomes:
measure: hospital mortality, organ-failure free days, pulmonary gas exchange
timeFrame: 28 days - 60 days
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: University Hospital Regensburg
Study officials:
affiliation: University Hospital Regensburg
name: Thomas Bein, Professor Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University Hospital Berlin
name: Steffen Weber-Carstens, Dr.
role: STUDY_CHAIR
affiliation: University Hospital Vienna, Austria
name: Thomas Staudinger, Prof
role: STUDY_CHAIR
affiliation: University Hospital Leipzig, Germany
name: Sven Bercker, MD
role: STUDY_CHAIR
affiliation: University Hospital Würzburg, Germany
name: Ralph Müllenbach, MD PhD
role: STUDY_CHAIR
affiliation: University Hospital Aachen, Germany
name: Rolf Dembinski, MD PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1097/01.CCM.0000215111.85483.BD.
citation: Bein T, Weber-Carstens S, Goldmann A, Muller 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 ( approximately 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.