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Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

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

U.S. FDA Resources

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
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852605

Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Illmer Thomas, Ph D Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00852605     History of Changes
Other Study ID Numbers: NIV2001
Study First Received: February 26, 2009
Last Updated: February 26, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on March 03, 2015