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Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

This study has been completed.
Sponsor:
Information provided by:
Dresden University of Technology
ClinicalTrials.gov Identifier:
NCT00852605
First received: February 26, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted

February 26, 2009
February 26, 2009
December 2001
August 2005   (final data collection date for primary outcome measure)
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No Changes Posted
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Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment
A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation

Acute lung injury (ALI) is an early complication after allogeneic transplantation causing significant mortality and morbidity. Little is known on early markers and treatment of this complication. Recent data (Hilbert et al.) suggested a beneficial effect of Non-Invasive-Ventilation in ALI-patients immunosuppressed because a many different reasons including stem-cell transplantation.

The investigators study is designed to evaluate early markers of ALI after allogeneic transplantation. In case ALI is documented patients are randomized to either conventional therapy (oxygen-support) or conventional therapy plus intermittent Non-Invasive Ventilation. The hypothesis is that Non-Invasive Ventilation improves outcome of ALI after allogeneic transplantation.
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Interventional
Phase 1
Phase 2
Allocation: Randomized
Masking: Open Label
Acute Lung Injury
Other: Intermittent Non-Invasive Ventilation
  • No Intervention: Oxygen
    Conventional Treatment including Oxygen-support
  • Experimental: NIV
    Conventional Treatment plus intermittent Non-Invasive-Ventilation
    Intervention: Other: Intermittent Non-Invasive Ventilation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
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August 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

patients undergoing allogeneic transplantation presenting with at least two of the following criteria

  • Respiratory rate >25 / min
  • Oxygenation Index <300
  • Continuous oxygen-saturation <92% whilst breathing room air

Exclusion Criteria:

  • Indication for Emergency intubation
  • Hemodynamic instability
  • Left ventricular failure
  • GCS <8
  • No consent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00852605
NIV2001
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Dresden University of Technology
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Principal Investigator: Illmer Thomas, Ph D Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden
Dresden University of Technology
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP