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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure

Intervention / Treatment
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* Drug: conventional ECMO with intravenous steroid
* Drug: solumedrol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of the patients had failure of at least 2 organs acquiring arteriovenous or venovenous ECMO support All of the patients met the criteria as below: blood gas parameters of PaO2/FiO2 < 100 bilateral pulmonary infiltration on chest radiographic images 100% oxygen demand in case of ventilation and ECMO flow hemodynamic instability requiring high catecholamine infusion All the patients had scoring system, which were calculated by the physician within 24 h of admission of the patients into the hospital. sequential organ failure assessment score (SOFA) ≥ 10 Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 20 inotropic score ≥ 10 multiple organ dysfunction (MOD) score ≥ 10 Exclusion Criteria: uncontrollable underlying disease life expectancy of less than 24 h immunosuppression neutrophil count of less than 0.3 × 109/L brainstem death history of long-term corticosteroid use during the past 6 months.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 87 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: conventional ECMO with intravenous steroid<br>refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation | Drug: conventional ECMO with intravenous steroid<br>* refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable<br>* Other names: Solu-Cortef;|
| Experimental: Drug: intrapleural steroid instillation<br>refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation | Drug: solumedrol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival until discharge from the hospital | Comparing the difference between two groups about the survival ratio of discharge from the hospital | 2005 2009 (up to 4 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications | complication of the interventional treatment will be followed for the duration of hospital stay | 12 weeks | 
| the effects on tidal volumes | the therapeutic effects in the improvement of tidal volumes, followed for the duration of ventilator usage | up to 12 weeks | 
| the therapeutic effects on oxygenation | the therapeutic effects in the improvement of oxygenation, followed for the duration of hospital stay | up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Respiratory Distress Syndrome, Multi-organ Dysfunction Syndrome, Extracorporeal Membrane Oxygenation