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

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Taiwan University Hospital
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

1. All of the patients had failure of at least 2 organs acquiring arteriovenous or venovenous ECMO support

2. 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:

1. uncontrollable underlying disease

2. life expectancy of less than 24 h

3. immunosuppression

4. neutrophil count of less than 0.3 × 109/L

5. brainstem death

6. history of long-term corticosteroid use during the past 6 months.