Acute Lung Injury After Allogeneic Transplantation - Diagnosis and Early Treatment

Technische Universität Dresden

Status and phase: Completed; Phase 2; Phase 1

Conditions: Acute Lung Injury

Treatments: Other: Intermittent Non-Invasive Ventilation

Study type: Interventional

Funder types: Other

Identifiers

NCT00852605

NIV2001

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

86 participants in 2 patient groups

Oxygen

No Intervention group

Description:

Conventional Treatment including Oxygen-support

NIV

Experimental group

Description:

Conventional Treatment plus intermittent Non-Invasive-Ventilation

Treatment:

Other: Intermittent Non-Invasive Ventilation