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OpenTrials
Completed

NCT Number: NCT00852605

Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

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.

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Key information

Conditions

Acute Lung Injury Lung Diseases Lung Injury Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intermittent Non-Invasive Ventilation

Other

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

A Randomized Clinical Trial on the Use of Early Intermittent Non-Invasive Ventilation in Patients Suffering From Acute Lung Injury After Allogeneic Transplantation

Important dates

Study start
2001
Primary completion
2005
First posted
Feb 27, 2009
Registry last updated
Feb 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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