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Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

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ClinicalTrials.gov Identifier: NCT00852605
Recruitment Status : Completed
First Posted : February 27, 2009
Last Update Posted : February 27, 2009
Sponsor:
Information provided by:
Technische Universität Dresden

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Acute Lung Injury Other: Intermittent Non-Invasive Ventilation Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Masking: None (Open Label)
Official Title: A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation
Study Start Date : December 2001
Actual Primary Completion Date : August 2005

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Arms and Interventions
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Arm Intervention/treatment
No Intervention: Oxygen
Conventional Treatment including Oxygen-support
Experimental: NIV
Conventional Treatment plus intermittent Non-Invasive-Ventilation
 Other: Intermittent Non-Invasive Ventilation


Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00852605


Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Illmer Thomas, Ph D Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00852605     History of Changes
Other Study ID Numbers: NIV2001
First Posted: February 27, 2009    Key Record Dates
Last Update Posted: February 27, 2009
Last Verified: February 2009

Keywords provided by Technische Universität Dresden:
Acute Lung Injury after allogeneic transplantation

Additional relevant MeSH terms:
Wounds and Injuries
Lung Injury
Acute Lung Injury
Respiratory Distress Syndrome, Adult
 Lung Diseases
Respiratory Tract Diseases
Thoracic Injuries
Respiration Disorders