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Table 2 Ongoing/planned clinical trials in ARDS

From: Pharmacological treatments in ARDS; a state-of-the-art update

Study reference number Study title and abbreviation Design Population A) Timing B) P/F ratio Anticipated enrollment Intervention Primary outcome Status
NCT01731795 Efficacy Study of Dexamethasone to Treat the Acute Respiratory Distress Syndrome (DEXA-ARDS) Phase 2/3 RCT A) 24 hours from ARDS onset B) <200 314 Dexamethasone (20 mg/day for five days, then 10 mg/day for five days) Ventilator-free days Not yet recruiting
NCT01284452 Efficacy of hydrocortisone in treatment of severe sepsis/septic shock patients with ALI/ARDS Phase 2/3 RCT A) 12 hours from organ dysfunction B) <300 194 Hydrocortisone 50 mg every six hours for seven days 28-day all-cause mortality Recruiting
ISRCTN88244364 Simvastatin in acute lung injury (HARP-2) [20] Phase 2/3 RCT A) 48 hours from ALI onset B) <300 540 Simvastatin 80 mg daily Ventilator-free days Recruiting
NCT00979121 Statins for Acutely Injured Lungs from Sepsis (SAILS) Phase 3 RCT A) 48 hours from ALI onset B) <300 1000 Rosuvastatin 20 mg daily Hospital mortality Day 60 Recruiting
ACTRN12612000418875 Nebulized heparin for lung injury Phase 2 RCT A) Within 24 hours of mechanical ventilation in at-risk patients B) <300 256 Nebulised Heparin 25,000 international units, every six hours for up to 10 days Physical function assessed using physical function component of SF-36 health survey Not yet recruiting
NCT01659307 The effect of Aspirin on REducing iNflammation in human in vivo model of Acute lung injury (ARENA) Phase 2 RCT Healthy, non-smoking adults, using an LPS model of ALI 33 Aspirin 75 mg or Aspirin 1,200 mg Bronchalveolar lavage intraleukin-8 concentration Not yet recruiting
NCT01504867 LIPS-A: Lung Injury Prevention Study with Aspirin Phase 2 RCT Adults admitted to hospital via the emergency department at high-risk of developing ALI 400 Aspirin 325 mg Day 1, then 81 mg daily days 2 to 7 Development of ARDS Recruiting
ISRCTN95690673 Keratinocyte growth factor in acute lung injury to reduce pulmonary dysfunction (KARE) [28] Phase 2 RCT A) 48 hours from ALI onset B) <300 60 Palifermin 60 μg/kg IV daily for up to six days Oxygenation index at Day 7 Recruiting
ISRCTN27673620 VItamiN D Replacement to Prevent Acute Lung Injury following OesophagectOmy (VINDALOO) [34] Phase 1/2 RCT Adults undergoing planned transthoracic esophagectomy 80 Oral Vitamin D (100,000 IU) EVLW at end of procedure Recruiting
NCT00789685 Safety, tolerability and preliminary efficacy of FP-1201 in ALI and ARDS Phase 1/2 Non-randomized A) 48 hours from ALI onset B) <300 37 Interferon-β, increasing dose over six days Clinically significant treatment emergent events, and all-cause mortality Completed