Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
Condition: Acute Respiratory Distress Syndrome (ARDS); Multiple Organ Failure
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Syndrome; Multiple Organ Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Acute respiratory distress syndrome (ARDS) in combination with multi-organ dysfunction
      syndrome (MODS) is a life-threatening condition, particularly when treatment modalities such
      as extracorporeal membrane oxygenation (ECMO) and catecholamine administration have failed to
      treat the severe condition. In this study, the investigators report patients who responded to
      intrapleural steroid instillation (IPSI) while being unresponsive to conventional treatment
      (use of intravenous steroids, nitric oxide inhalation, high-frequency oscillatory
      ventilation, or ECMO) for treatment of critical illnesses such as ARDS in combination with
      MODS.
    

Detailed description: 
      Acute respiratory distress syndrome (ARDS) with multi-organ dysfunction syndrome (MODS) are
      common debilitating postoperative complications, which also result from shock and trauma.
      However, despite the use of ECMO, mortality rate among hypoxia patients remains high in such
      critical care conditions. Corticosteroid therapy inhibits ongoing inflammation and abnormal
      deposition of collagen. However, intravenous administration of corticosteroids may be harmful
      because it may increase the risk of associated neuromyopathy in critically ill patients.
      Although intrapleural instillation of steroids has been employed in several pleural
      diseases,little is known about the therapeutic effects of this treatment method on ARDS in
      combination with MODS. Therefore, in the present pilot study, the investigators hypothesized
      that timely initiation of intrapleural steroid instillation (IPSI) will positively influence
      ventilation in and survival of patients with ARDS in combination with MODS.

      The investigators conducted a retrospective study on ninety-two of the 467 ECMOs performed
      between 2005 and 2009 were on ARDS patients. Analyses of gas exchange, tidal volumes, airway
      pressures, respiratory frequency, and vasopressor and sedation requirements were performed
      before and after intervention.

      The indication for IPSI was unresponsive severe ARDS in combination with MODS when all the
      other treatment modalities such as intravenous steroid administration, nitric oxide
      inhalation, high-frequency oscillatory ventilation, or ECMO performed within 2 days were
      unsuccessful.

      An experienced team performed thoracic catheterization of the patients under ultrasound
      evaluation. Patients with severe pleural adhesion were considered unsuitable for IPSI. The
      dosage of the intrapleural steroid was determined on the basis of the chest radiographic
      examination, inspired oxygen concentration, and positive end-expiratory pressure (PEEP) of
      the ventilator.
    

Intervention name(s): conventional ECMO with intravenous steroid; solumedrol
Intervention type(s): Drug; Drug
Intervention description(s): refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable; Initially, intrapleural steroid administration was performed using 40 mg solumedrol q6h (for both the pleural cavities). If chest radiography showed an improvement in consolidation, i.e., 0.8 > FiO2 ≥ 0.5 and 5 ≤ PEEP ≤ 10, the dosage of solumedrol was reduced to 40 mg q12h. When FiO2 was below 0.5 and the PEEP was below 10, the dosage of solumedrol was lowered to 40 mg qd for 3 days and then its administration was discontinued.
Other intervention name(s): Solu-Cortef
Intervention MeSH terms: Methylprednisolone Hemisuccinate; Methylprednisolone Acetate; Methylprednisolone; Prednisolone; Prednisolone acetate; Hydrocortisone hemisuccinate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute Respiratory Distress Syndrome; Multi-organ Dysfunction Syndrome; Extracorporeal Membrane Oxygenation