Streptokinase Versus Unfractionated Heparin Nebulization in Severe ARDS

• Status: Completed
• Trial end date: 2018-01-30
• Target enrollment: 0
• Participant gender: All

Summary

Background: Intra-alveolar clotting and alveolar collapse in ARDS is due to alveolar capillaries epithelial and leakage. Subsequently, collapse induces hypoxemia that is resistant to recruitment (RM). Heparin and Streptokinase may prevent or dissolve intra-alveolar fibrin clot respectively helping alveolar re-expansion. We examined and compared the effect of nebulizing Heparin versus Streptokinase on reversing this pathology.

Methods: Sixty severe ARDS (PaO2/FiO2<100) patients and failure of RM, prone position (PP) and neuromuscular block (NMB) were partially randomised into Group (I): (n=20) received nebulized Heparin 10000 IU/4h. Group (II): (n=20) received nebulized Streptokinase 250,000 IU/4h. Group (III): (n=20) received conservative management. Randomization to either Heparin or Streptokinase groups was applied to patients whom guardian accepted participation, while those who declined participation were followed-up as a control. The primary outcome was the change in PaO2/FiO2; the secondary outcomes included the change in compliance, plateau pressure, ventilation-off days, coagulation and ICU mortality.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beni-Suef University
• Treatments: Calcium heparin; Heparin; Streptokinase

Criteria

Inclusion Criteria:

• Severe ARDS with PO2/FiO2 ratio<100.

• Failure of Recruitment Maneuver (RM), Prone Position (PP) or Neuro-Muscular Block (NMB) to improve hypoxemia.

• No contraindications to thrombolytic or anticoagulant therapy (e.g. Coagulopathy, Heparin-Induced Thrombocytopenia, Previous administration of streptokinase, Known or suspected allergy to heparin or streptokinase, History of intracranial hemorrhage in the past 12 months, Patients with an epidural catheter in place or likely to be placed within the next 48 h.).

• Static compliance <50 ml/cmH2O

Exclusion Criteria:

• PO2/FiO2 ratio>100.

• The success of Recruitment Maneuver (RM), Prone Position (PP) or Neuro-Muscular Block (NMB) to improve hypoxemia.

• Contraindications to thrombolytic or anticoagulant therapy (e.g. Coagulopathy, Heparin-Induced Thrombocytopenia, Previous administration of streptokinase, Known or suspected allergy to heparin or streptokinase, History of intracranial hemorrhage in the past 12 months, Patients with an epidural catheter in place or likely to be placed within the next 48 h.)

• Static compliance >50 ml/cmH2O