Acute Respiratory Distress Network (ARDSNet) Study 04 Assessment of Low tidal Volume and elevated End-expiratory volume to Obviate Lung Injury (ALVEOLI)

HLB00500606a

ARDSNet-ALVEOLI

False

Released

True

True

Coded

http://www.ardsnet.org/

False

Clinical Trial

Open BioLINCC Study

Both

Procedure: Low Tidal Volume VentilationProcedure: Positive End-Expiratory PressureDrug: LysofyllineDrug: MethylprednisoloneDrug: KetoconazoleProcedure: Fluid ManagementProcedure: Pulmonary Artery Catheter

2009-10-01

2010-04-09

2008-10-13

2006-08-24

1999-2002

DLD

Lung

non-HIV

non-COVID

3874

0

No

No

No

No

Yes, For Some Specimens

No

ALI
ARDS
Acute Lung Injury
Lung Diseases
Respiratory Distress Syndrome, Adult

The ARDS Network is a consortium of clinical centers and a coordinating center to design and test novel therapies for the treatment of Acute Lung Injury (ALI) and Acute Respiratory Distress Syndrome (ARDS). The ARDS Network 01/03 trials included an investigation of the efficacy and safety of Ketoconazole and Respiratory Management in the treatment of ALI and ARDS (KARMA). The Ketoconazole arm of the KARMA study was later stopped due to an inability to show efficacy. Patients continued to be randomized to the respiratory management arms of the study (ARMA), which compared two ventilator strategies: a tidal volume of 6 mL/kg versus 12 mL/kg. The LARMA phase of the study investigated the efficacy of Lisofylline and Respiratory Management. The objective of the ALVEOLI study was to compare clinical outcomes of patients with ALI and ARDS treated with a higher end-expiratory lung volume/lower FiO2 versus a lower end-expiratory lung volume/higher FiO2 ventilation strategy. The ALVEOLI study tested the hypothesis that mortality from ALI and ARDS would be reduced with a mechanical ventilation strategy designed to prevent lung injury from repeated collapse of bronchioles and alveoli at end-expiration.

Most patients requiring mechanical ventilation for ALI and ARDS receive positive end-expiratory pressure (PEEP) of 5 to 12 cm of water. Higher PEEP levels may improve oxygenation and reduce ventilator-induced lung injury but may also cause circulatory depression and lung injury from overdistention. PEEP levels higher than traditional levels may reduce ventilator-induced lung injury by decreasing the proportion of nonaerated lung and higher PEEP levels may allow arterial-oxygenation goals to be met at a lower level of inspired oxygen (FiO2).

Patients 14 years of age or more, intubated and receiving mechanical ventilation with a sudden decrease in the ratio of the partial pressure of arterial oxygen (PaO2) to FiO2 of 300 or less, recent appearance of bilateral pulmonary infiltrates consistent with the presence of edema, and no evidence of left atrial hypertension. A total of 549 patients were randomized to receive mechanical ventilation with either lower or higher PEEP levels, which were set according to different tables of predetermined combinations of PEEP and fraction of inspired oxygen.

Patients with acute lung injury and ARDS who receive mechanical ventilation with a tidal-volume goal of 6 ml per kilogram of predicted body weight and an end-inspiratory plateau-pressure limit of 30 cm of water, clinical outcomes were statistically similar whether lower or higher PEEP levels are used. (N Engl J Med 2004;351:327-336).

DNA
Plasma

Acute Respiratory Distress Network (ARDSNet)