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 |