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Extrapulmonary Interventional Ventilatory Support in Severe Acute Respiratory Distress Syndrome (ARDS) (Xtravent)
This study has been completed.
Sponsor:
University of Regensburg
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
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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 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:
Respiratory Distress Syndrome, Infant
Acute Respiratory Distress Syndrome
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 ]
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 |
| 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 (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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00538928
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
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 |
ClinicalTrials.gov processed this record on June 21, 2017