Streptokinase Versus Unfractionated Heparin Nebulization in Patients With Severe Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial With Observational Controls.

OBJECTIVE: To examine and compare nebulizing heparin versus streptokinase for reversing alveolar collapse nonresponsive to recruitment.
DESIGN: A clinical trial at a tertiary intensive care unit (ICU). Sixty patients with severe acute respiratory distress syndrome (ARDS) (PaO2/FIO2 <100) nonresponsive to recruitment maneuver (RM), prone position, and neuromuscular block (NMB) were randomized into intervention arms or the standard-of-care arm.
SETTING: The ICU at Beni-Suef University Hospital. PARTICIPANTS: Sixty patients with severe ARDS (PaO2/FIO2 <100) nonresponsive to RM, PP, and NMB.
INTERVENTIONS: Nebulized heparin (10,000 IU/4 h), nebulized streptokinase (250,000 IU/4 h), and conservative management.
MEASUREMENTS AND MAIN RESULTS: The primary outcome was the change in PaO2/FIO2; the secondary outcomes included the change in compliance, plateau pressure, coagulation, and ICU mortality. The PaO2/FIO2 was significantly higher in the streptokinase group from day 1 to day 8 compared to the heparin and standard-of-care groups. Streptokinase produced PaO2/FIO2>100 at day 1, >200 at day 5, and >300 at day 7. The heparin group achieved a PaO2/FIO2 >100 at day 5 but remained <200 until day 8. The standard-of-care group did not achieve a PaO2/FIO2>100 after 8 days. Streptokinase significantly reduced plateau pressure and improved compliance at day 8. Only streptokinase decreased PaCO2 (p < 0.0001). Moreover, ICU mortality was significantly lower in streptokinase patients compared to other groups. Additionally, no heparin-induced thrombocytopenia was observed in all groups.
CONCLUSION: Inhaled streptokinase serves as rescue therapy in patients with severe ARDS with improving oxygenation and lung mechanics more quickly than heparin or conventional management.

RCT Entities:   Population Interventions Outcomes