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Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00852605
First Posted: February 27, 2009
Last Update Posted: February 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Technische Universität Dresden
  Purpose

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 Intervention Phase
Acute Lung Injury Other: Intermittent Non-Invasive Ventilation Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Enrollment: 86
Study Start Date: December 2001
Primary Completion Date: August 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Oxygen
Conventional Treatment including Oxygen-support
Experimental: NIV
Conventional Treatment plus intermittent Non-Invasive-Ventilation
Other: Intermittent Non-Invasive Ventilation

  Eligibility

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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

ClinicalTrials.gov Identifier: NCT00852605     History of Changes
Other Study ID Numbers: NIV2001
First Submitted: February 26, 2009
First Posted: February 27, 2009
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