Clinical Trial: Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome

Brief 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 Summary:

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 t
Sponsor: National Taiwan University Hospital

Current Primary Outcome: survival until discharge from the hospital [ Time Frame: 2005~2009 (up to 4 years) ]

Comparing the difference between two groups about the survival ratio of discharge from the hospital


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of complications [ Time Frame: 12 weeks ]
    complication of the interventional treatment will be followed for the duration of hospital stay
  • the effects on tidal volumes [ Time Frame: up to 12 weeks ]
    the therapeutic effects in the improvement of tidal volumes, followed for the duration of ventilator usage
  • the therapeutic effects on oxygenation [ Time Frame: up to 12 weeks ]
    the therapeutic effects in the improvement of oxygenation, followed for the duration of hospital stay


Original Secondary Outcome: Same as current

Information By: National Taiwan University Hospital

Dates:
Date Received: August 18, 2011
Date Started: June 2005
Date Completion:
Last Updated: August 25, 2011
Last Verified: August 2011