Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome (IP steroid)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01423864
First received: August 18, 2011
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Acute Respiratory Distress Syndrome (ARDS)
Multiple Organ Failure
Drug: conventional ECMO with intravenous steroid
Drug: solumedrol
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • survival until discharge from the hospital [ Time Frame: 2005~2009 (up to 4 years) ] [ Designated as safety issue: No ]
    Comparing the difference between two groups about the survival ratio of discharge from the hospital


Secondary Outcome Measures:
  • Incidence of complications [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    the therapeutic effects in the improvement of oxygenation, followed for the duration of hospital stay


Enrollment: 29
Study Start Date: June 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Sham Comparator: conventional ECMO with intravenous steroid
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation
Drug: conventional ECMO with intravenous steroid
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable
Other Name: Solu-Cortef
Experimental: Drug: intrapleural steroid instillation
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation
Drug: solumedrol
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.

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

Ages Eligible for Study:   16 Years to 87 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01423864

Locations
Taiwan
Department of Surgery, National Taiwan University Hospital
7, Chung-Shan S. Rd, Taipei 10002, Taiwan., Taiwan, 10002
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Pei-Ming Huang, MD, MS National Taiwan University Hospital and National Taiwan University College of Medicine
  More Information

Publications:

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01423864     History of Changes
Other Study ID Numbers: 200906014R
Study First Received: August 18, 2011
Last Updated: August 25, 2011
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Acute Respiratory Distress Syndrome
Multi-organ Dysfunction Syndrome
Extracorporeal Membrane Oxygenation

Additional relevant MeSH terms:
Acute Lung Injury
Multiple Organ Failure
Respiratory Distress Syndrome, Adult
Respiratory Distress Syndrome, Newborn
Syndrome
Disease
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Lung Injury
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Shock
Methylprednisolone
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on October 29, 2014