NCT00852605

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P75+ for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2005

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
Last Updated

February 27, 2009

Status Verified

February 1, 2009

Enrollment Period

3.7 years

First QC Date

February 26, 2009

Last Update Submit

February 26, 2009

Conditions

Acute Lung Injury

Keywords

Acute Lung Injury after allogeneic transplantation

Study Arms (2)

Oxygen

NO INTERVENTION

Conventional Treatment including Oxygen-support

NIV

EXPERIMENTAL

Conventional Treatment plus intermittent Non-Invasive-Ventilation

Other: Intermittent Non-Invasive Ventilation

Interventions

Intermittent Non-Invasive VentilationOTHER
NIV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Indication for Emergency intubation
  • Hemodynamic instability
  • Left ventricular failure
  • GCS \<8
  • No consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Illmer Thomas, Ph D

    Medizinische Klinik I - Universitätsklinikum Carl-Gustav-Carus Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2009

First Posted

February 27, 2009

Study Start

December 1, 2001

Primary Completion

August 1, 2005

Last Updated

February 27, 2009

Record last verified: 2009-02