H1N1 Registry

A registry of patient in ICUs with H1N1 or H1N1-flu-like symptoms.

• H1N1 Registry
• Open

SAILS

Statins for Acutely Injured Lungs from Sepsis is a trial of rosuvastatin versus placebo comparator for the treatment of patients with ALI or ARDS.

ClinicalTrials.Gov Registration Page

• SAILS
• Open

EDEN - Omega

Prospective, Randomized Trial of initial trophic enteral feeding followed by advancement to full-calorie enteral feeding vs. early advancement to full-calorie enteral feeding. This trial will be run simultaneously with a trial of omega-3 fatty acid, gamma-linolenic acid, and anti-oxidant supplementation vs. a comparator.

ClinicalTrials.Gov Registration Page

These trials will test the safety and efficacy of these treatments in the management of patients with ALI or ARDS.

• EDEN-Omega
• Open

Albuterol for the Treatment of ALI (ALTA)

A prospective, randomized trial of Aerosolized Albuterol vs. Placebo to test the safety and efficacy of aerosolized beta-2 adrenergic agonist therapy for improving clinical outcomes in patients with acute lung injury.

ClinicalTrials.Gov Registration Page

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Consent Template

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ALTA Training

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FAQs

Enrollment and Randomization

Enrollment and Randomization

Protocol Questions

Protocol Questions

Heart Rate and Dosing

Heart Rate and Dosing

Ventilator Protocol Questions

Ventilator Protocol Questions

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Specimens and mini-BAL Questions

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• ALTA
• Closed

• Read more

Fluid and Catheter Treatment Trial

The FACTT study was a prospective, randomized, multi-center trial evaluating the use of a pulmonary artery catheter versus a less invasive alternative, the central venous catheter, for the management of patients with acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). It was combined with a second study contrasting a conservative and a liberal fluid management strategy in patients with ALI or ARDS.

• Study Synopsis

FACTT CRFs

• FACTT CRFs

Study Publications

• Pulmonary-Artery Versus Central Venous Catheter to Guide Treatment of Acute Lung Injury

• FACTT
• Completed

ALVEOLI

The ALVEOLI study was a prospective, randomized, controlled multi-center trial. The objective was to compare clinical outcomes of patients with acute lung injury (ALI)and acute respiratory distress syndrome (ARDS) treated with a higher end-expiratory lung volume/lower FiO2 versus a lower end-expiratory lung volume/higher FiO2 ventilation strategy.

• Study Synopsis

• ALVEOLI
• Completed

Lysophylline for ALI/ARDS

The LARMA study was a randomized, double-blind, placebo- controlled multi-center 2 x 2 factorial study where each patient was randomized between Lisofylline and Placebo. It was designed to test whether the administration of lisofylline early after the onset of ALI or ARDS would reduce mortality and morbidity.

• Study Synopsis

• LARMA
• Completed

Late Steroid Rescue Study

The late phase of ARDS is often characterized by excessive fibroproliferation leading to gas exchange and compliance abnormalities. The objective of the LaSRS study was to determine if the administration of corticosteroids, in the form of methylprednisolone sodium succinate, in severe late-phase ARDS, would have a positive effect on this fibroproliferation, thereby reducing mortality and morbidity.

The results were published in: Efficacy and Safety of Corticosteroids for Persistent Acute Respiratory Distress Syndrome Steinberg, KP; Hudson, LD; Goodman, RB; Hough, CL; Lanken, PN; Hyzy, R; Thompson, BT; Ancukiewicz, M; NIH / NHLBI ARDSNet, New Engl J Med, May 25, Volume 354, Issue 16, p.1671-1684, (2006)

• Study Synopsis

• LaSRS
• Completed

Ketoconazole for ALI/ARDS

The first clinical trial completed by the Network was a randomized, controlled trial of Ketoconazole versus placebo in patients with acute lung injury and ARDS.

Ketoconazole was chosen because of its anti-inflammatory actions noted in the laboratory and because previous Phase II clinical trials suggested benefit in patients with or at risk for ARDS. This trial was stopped early by the DSMB in January 1997 after finding Ketoconazole to be ineffective. The clinical trial results were published in JAMA in April 2000 (The ARDS Clinical Trials Network Authors for the ARDS Network. Ketoconazole for early treatment of Acute Lung Injury and Acute Respiratory Distress Syndrome. A randomized controlled trial. JAMA, 2000;283:1995-2002).

• Study Synopsis

• KARMA
• Completed

Lower Tidal Volume Trial

The ARMA study was a randomized, controlled multi-center 2 x 2 factorial study consisting of a drug treatment (Ketoconazole vs. placebo) and a ventilation strategy (6ml/kg tidal volume vs. 12ml/kg tidal volume).

The ventilator arm of the protocol was designed to compare different ventilator strategies and their effect on mortality and morbidity. The lower tidal volume strategy (6 ml/kg) improved survival and the study was stopped early. The drug arm of the protocol, Ketoconazole did not show promise and was subsequently stopped.

• Study Synopsis

• ARMA
• Completed