Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

This study has been completed.

Sponsor:

Information provided by:

Technische Universität Dresden

ClinicalTrials.gov Identifier:

NCT00852605

First received: February 26, 2009

Last updated: NA

Last verified: February 2009

History: No changes posted

Purpose

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	Intervention	Phase
Acute Lung Injury	Other: Intermittent Non-Invasive Ventilation	Phase 1 Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: 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

Resource links provided by NLM:

Genetic and Rare Diseases Information Center resources: Acute Respiratory Distress Syndrome Respiratory Distress Syndrome, Infant

U.S. FDA Resources

Further study details as provided by Technische Universität Dresden:


Enrollment:	86
Study Start Date:	December 2001
Primary Completion Date:	August 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Oxygen Conventional Treatment including Oxygen-support
Experimental: NIV Conventional Treatment plus intermittent Non-Invasive-Ventilation	Other: Intermittent Non-Invasive Ventilation

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852605

Sponsors and Collaborators

Technische Universität Dresden

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00852605 History of Changes
Other Study ID Numbers:	NIV2001
Study First Received:	February 26, 2009
Last Updated:	February 26, 2009
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 27, 2016

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