Clinical trial NCT01423864: Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
Official title: Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Respiratory Distress Syndrome (ARDS)
Multiple Organ Failure
Keywords: Acute Respiratory Distress Syndrome
Multi-organ Dysfunction Syndrome
Extracorporeal Membrane Oxygenation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-08-26
Enrollment: 29
Sex: ALL
Minimum age (years): 16
Maximum age (years): 87
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility 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.

Primary outcomes:
measure: survival until discharge from the hospital
timeFrame: 2005~2009 (up to 4 years)
Secondary outcomes:
measure: Incidence of complications
timeFrame: 12 weeks
measure: the effects on tidal volumes
timeFrame: up to 12 weeks
measure: the therapeutic effects on oxygenation
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: 7, Chung-Shan S. Rd, Taipei 10002, Taiwan.
country: Taiwan
facility: Department of Surgery, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital and National Taiwan University College of Medicine
name: Pei-Ming Huang, MD, MS
role: PRINCIPAL_INVESTIGATOR
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