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
|
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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 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 |

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

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

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
Principal Investigator: | Illmer Thomas, Ph D | Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden |
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 |