NHLBI ARDS Network TRIALS

The NHLBI ARDS Network enrolled 5,527 patients across ten randomized controlled trials and one observational study.

ARDS NET TRIAL

Ketoconazole for ALI/ARDS (KARMA)

Mar 1996 – Feb 1998

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. It enrolled 234 participants.

Lower Tidal Volume Trial (ARMA)

Mar 1996 – Jul 1999

The ARMA study was a randomized, controlled multi-center 2×2 factorial study consisting of a drug treatment (Ketoconazole vs. placebo) and a ventilation strategy (6ml/kg tidal volume vs. 12ml/kg tidal volume). It enrolled 861 participants.

Lisofylline for ALI/ARDS (LARMA)

Feb 1998 – Jun 1999

The LARMA study was a randomized, double-blind, placebo-controlled multi-center study with 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. It was also conducted in a 2×2 factorial in the later stages of the ARMA trial. It enrolled 236 participants.

Late Steroid Rescue Study (LaSRS)

Aug 1997 – Nov 2003

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. It enrolled 180 particpants.

Higher vs Lower PEEP (ALVEOLI)

Nov 1999 – Mar 2002

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. It enrolled 549 participants.

Fluid and Catheter Treatment Trial (FACTT)

Jun 2000 – Oct 2005

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 in a 2×2 factorial design with a second study contrasting a conservative and a liberal fluid management strategy in patients with ALI or ARDS. It enrolled 1000 participants.

Albuterol for the Treatment of ALI (ALTA)

Aug 2007 – Sep 2008

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. It enrolled 282 participants.

Early vs. Delayed Enteral Nutrition (EDEN)

Nov 2006 – Mar 2011

Prospective, Randomized Trial of initial trophic enteral feeding followed by advancement to full-calorie enteral feeding vs. early advancement to full-calorie enteral feeding. It enrolled 1000 participants. This trial was originally run as a 2×2 factorial trial with the Omega trial. When the Omega arm was stopped for futility, the EDEN arm continued to completion.

Omega Nutrition Supplement Trial (Omega)

Nov 2006 – Apr 2009

@TODO A trial of omega-3 fatty acid, gamma-linolenic acid, and anti-oxidant supplementation vs. a comparator. It enrolled 272 participants. It was run as a part of a 2×2 factorial trial with the EDEN study. The Omega arm was stopped for futility.

H1N1 Registry

Nov 2009 – Jun 2010

A registry created in collaboration with the CDC to track severe cases of H1N1. It enrolled 683 participants.

Rosuvastatin vs. Placebo (SAILS)

Mar 2010 – Sep 2013

Statins for Acutely Injured Lungs from Sepsis is a trial of rosuvastatin versus placebo comparator for the treatment of patients with ALI or ARDS. It enrolled 745 participants.

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