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Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

NCT ID: NCT00852605

Last Updated: 2009-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Lung Injury

Keywords

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Acute Lung Injury after allogeneic transplantation

Study Design

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Allocation Method

RANDOMIZED

Blinding Strategy

NONE

Study Groups

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Oxygen

Conventional Treatment including Oxygen-support

Group Type NO_INTERVENTION

No interventions assigned to this group

NIV

Conventional Treatment plus intermittent Non-Invasive-Ventilation

Group Type EXPERIMENTAL

Intermittent Non-Invasive Ventilation

Intervention Type OTHER

Interventions

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Intermittent Non-Invasive Ventilation

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Principal Investigators

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Illmer Thomas, Ph D

Role: PRINCIPAL_INVESTIGATOR

Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden

Other Identifiers

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NIV2001

Identifier Type: -

Identifier Source: org_study_id