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

Primary Purpose

Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
conventional ECMO with intravenous steroid
solumedrol
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome (ARDS) focused on measuring Acute Respiratory Distress Syndrome, Multi-organ Dysfunction Syndrome, Extracorporeal Membrane Oxygenation

Eligibility Criteria

16 Years - 87 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Surgery, National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

conventional ECMO with intravenous steroid

Drug: intrapleural steroid instillation

Arm Description

refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation

refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Incidence of complications
complication of the interventional treatment will be followed for the duration of hospital stay
the effects on tidal volumes
the therapeutic effects in the improvement of tidal volumes, followed for the duration of ventilator usage
the therapeutic effects on oxygenation
the therapeutic effects in the improvement of oxygenation, followed for the duration of hospital stay

Full Information

First Posted
August 18, 2011
Last Updated
August 25, 2011
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01423864
Brief Title
Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
Acronym
IP steroid
Official Title
Retrospective Study of Intrapleural Methylprednisolone Injection for Multiple Organ Failure With Acute Respiratory Distress Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
June 2005 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome (ARDS), Multiple Organ Failure
Keywords
Acute Respiratory Distress Syndrome, Multi-organ Dysfunction Syndrome, Extracorporeal Membrane Oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
conventional ECMO with intravenous steroid
Arm Type
Sham Comparator
Arm Description
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation
Arm Title
Drug: intrapleural steroid instillation
Arm Type
Experimental
Arm Description
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome unresponsive to conventional extracorporeal membrane oxygenation
Intervention Type
Drug
Intervention Name(s)
conventional ECMO with intravenous steroid
Other Intervention Name(s)
Solu-Cortef
Intervention Description
refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable
Intervention Type
Drug
Intervention Name(s)
solumedrol
Intervention Description
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.
Primary Outcome Measure Information:
Title
survival until discharge from the hospital
Description
Comparing the difference between two groups about the survival ratio of discharge from the hospital
Time Frame
2005~2009 (up to 4 years)
Secondary Outcome Measure Information:
Title
Incidence of complications
Description
complication of the interventional treatment will be followed for the duration of hospital stay
Time Frame
12 weeks
Title
the effects on tidal volumes
Description
the therapeutic effects in the improvement of tidal volumes, followed for the duration of ventilator usage
Time Frame
up to 12 weeks
Title
the therapeutic effects on oxygenation
Description
the therapeutic effects in the improvement of oxygenation, followed for the duration of hospital stay
Time Frame
up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
87 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei-Ming Huang, MD, MS
Organizational Affiliation
National Taiwan University Hospital and National Taiwan University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Surgery, National Taiwan University Hospital
City
7, Chung-Shan S. Rd, Taipei 10002, Taiwan.
ZIP/Postal Code
10002
Country
Taiwan

12. IPD Sharing Statement

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

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