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

NCT00538928 | Completed DMC

• 1 other identifier: KKS 4012-001-07
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

acute respiratory distress syndrome; extracorporeal lung support; hypoxia; hypercapnia; acute respiratory distress syndrome (ARDS)

Outcome Measures

Primary Outcomes (1)

• Ventilator free days within 28 days after enrollment

  28 days

Secondary Outcomes (1)

• hospital mortality, organ-failure free days, pulmonary gas exchange

  28 days - 60 days

Study Arms (2)

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

Interventions

lung protective ventilation OTHER

tidal volume 6 ml/kg ideal body weight

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Regensburg: lead
• Charite University, Berlin, Germany: collaborator

Study Sites (1)

University Hospital Regensburg

Regensburg, 93042, Germany

Location

Related Publications (2)

• 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.

  PMID: 16540950 BACKGROUND

• 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.

  PMID: 23306584 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypoxia; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Bein, Professor Dr.

  University Hospital Regensburg

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 2, 2007
• First Posted: October 3, 2007
• Study Start: September 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: March 2, 2011

Record last verified: 2009-03

Locations

DE (1)