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

Acute Respiratory Distress Syndrome Clinical Trial

— Xtravent  

Official title:

Extrapulmonary Interventional Ventilatory Support for Lung Protection in Severe Acute Respiratory Distress - a Prospective Randomized Multi Centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00538928
• Other study ID #: KKS 4012-001-07
• Status: Completed
• Phase: N/A
• First received: October 2, 2007
• Last updated: March 1, 2011
• Start date: September 2007
• Est. completion date: January 2011

Study information

• Verified date: March 2009
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Koordinierungsstelle für klinische Studien (KKS) Charite Berlin
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Other:
• lung protective ventilation
tidal volume 6 ml/kg ideal body weight

Locations

Country	Name	City	State
Germany	University Hospital Regensburg	Regensburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Regensburg	Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free days within 28 days after enrollment		28 days	Yes
Secondary	hospital mortality, organ-failure free days, pulmonary gas exchange		28 days - 60 days	Yes