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NCT00852605 Clinical Trial

Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

Acute Lung Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00852605
Other study ID # NIV2001
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received February 26, 2009
Last updated February 26, 2009
Start date December 2001

Study information
Verified date February 2009
Source Technische Universität Dresden
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 86
Est. completion date
Est. primary completion date August 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• Intermittent Non-Invasive Ventilation

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Technische Universität Dresden
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