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6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome (NAIF)

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ClinicalTrials.gov Identifier: NCT00127985
Recruitment Status : Unknown
Verified May 2008 by Hospital Universitario Principe de Asturias.
Recruitment status was:  Recruiting
First Posted : August 9, 2005
Last Update Posted : May 13, 2008
Sponsor:
Collaborator:
Pfizer
Information provided by:
Hospital Universitario Principe de Asturias

Study Description
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Brief Summary:

Background: Systemic corticosteroids are considered in patients with an adverse clinical course suffering from conditions like the acute respiratory distress syndrome (ARDS) and septic shock. Treated patients not only show improved respiratory function, but also hemodynamic status and overall multiple organ dysfunction score.

Objective: To evaluate the safety and effectiveness of 6-methyl-prednisolone on the clinical course of multiple organ dysfunction syndrome (MODS).

Design: Multi-center, double-blind, randomized, placebo-controlled.

Intervention: Intravenous administration of 6-methyl-prednisolone or placebo (aqueous solution). The duration of the study medication administration protocol is 32 days (1).

Primary Endpoints:

  1. All cause Intensive Care Unit (ICU) and 28-day mortality
  2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.

Condition or disease Intervention/treatment Phase
Multiple Organ Dysfunction Syndrome Drug: 6-methyl-prednisolone Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome
Study Start Date : August 2005
Estimated Primary Completion Date : July 2008
Estimated Study Completion Date : July 2008

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Active
IV 6-methyl-prednisolone
 Drug: 6-methyl-prednisolone
iv, 2 mg/kg/day, qid
Placebo Comparator: Comparator
IV Placebo
 Drug: 6-methyl-prednisolone
iv, 2 mg/kg/day, qid


Outcome Measures
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Primary Outcome Measures :
  1. All cause ICU and 28-day mortality [ Time Frame: 28 days ]
  2. Organ dysfunction score on days 4, 7, 14, and 28 of the protocol [ Time Frame: Days 4, 7, 14, and 28. ]

Secondary Outcome Measures :
  1. Mortality [ Time Frame: 28 days ]
  2. Morbidity: Duration of mechanical ventilation and endotracheal intubation (also a surrogate for acute steroid myopathy) [ Time Frame: 28 days ]
  3. Length of ICU-stay [ Time Frame: 28 days ]
  4. Complications of steroid therapy [ Time Frame: 28 days ]
  5. Infections acquired during the protocol [ Time Frame: 28 days ]
  6. Other complications (hyperglycemia, GI bleeding, acute myopathy, pneumothorax) [ Time Frame: 28 days ]
  7. Adrenal reserve as evaluated by adrenocorticotropic hormone (ACTH) test. [ Time Frame: Baseline ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Main Inclusion Criteria:

Patients with established, unresolving, refractory MODS, in whom all reversible and treatable causes of persistent MODS have been treated or ruled out:

  • Patients under endotracheal intubation and mechanical ventilation for at least 7 days.
  • Aggregate Multiple Organ Dysfunction Score (5) of greater than 8 over the first seven days of mechanical ventilation and greater than 5 on the day of inclusion.
  • Written informed consent to participate in the trial signed by next of kin or other authorized person.

Additional Inclusion Criteria:

  • Main cause or disease at admission: Adequate "source control" is required and refers to optimal, complete, and definitive surgical and/or medical therapy.

  • Infections:

    1. Infectious causes of persistence of MODS have reasonably been ruled out on clinical or other grounds (infectious endocarditis, undrained abscesses like sinusitis, empyema or abdominal pus). Consider sampling for culture of broncho-alveolar lavage fluid, protected specimen brush or other (empyema fluid, lung tissue) in order to rule out respiratory infection, as well as intra-vascular catheter change and culture.
    2. Present or previous infections, either documented or strongly suspected, have been treated for at least 3 days before inclusion.
  • Supportive Care: Optimal hemodynamic, renal, hematologic, nutritional "supportive care" is provided.

Exclusion Criteria:

  • Decision not to provide full support.

  • Immune status and steroid therapy.

    1. Steroid therapy

      • Currently indicated for chronic or concurrent disease (meningitis, auto-immune disease, asthma, acute exacerbation of chronic obstructive pulmonary disease [COPD], or other). Inhaled steroids are allowed.
      • Administered during current admission (> 20 mg/day of 6-methyl-prednisolone or equivalent for >48 hours).
      • Chronic steroid therapy prior to current admission (> 20 mg of 6-methyl-prednisolone or equivalent/day for > 1 month during previous 3 months).
    2. Other immune-suppressive therapy within the previous 6 months.
    3. Known AIDS.
    4. Neutropenia < 500/mcl.
    5. Preceding organ transplantation.
  • Irreversible and or ultimately fatal clinical conditions like metastatic malignant disease or cardiogenic shock caused by coronary artery disease.
  • Presence of invasive fungal infection

  • Other significant pre-existing underlying chronic diseases:

    1. Severe parenchymal liver disease (Child-Pugh grade C)
    2. Severe and irreversible acute or chronic central nervous system disease.
    3. Severe end-stage chronic obstructive pulmonary disease (home oxygen or more than 1 exacerbation in previous year)
    4. End-stage renal disease (Chronic dialysis).
  • Age less than 18 years.
  • Pregnancy.
  • Morbid obesity: body mass index above 40.
  • Recent (last 3 months) upper gastrointestinal [GI] hemorrhage.
  • Extensive burns (>30% body surface area [BSA])
  • Known allergy to steroids.
  • Written informed consent not available.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127985


Contacts
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Contact: Miguel Sanchez, MD, PhD 34-91-887-8100 ext 2205 miguelsanchez.areachip@wanadoo.es

Locations
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Spain
Hospital Principe de Asturias Recruiting
Alcala de Henares, Madrid, Spain, 28805
Contact: Raul De Pablo    34-91-8871-8100 ext 2205    rdepablosanchez@yahoo.es   
Principal Investigator: Raul De Pablo, MD         
Hospital Clinic Recruiting
Barcelona, Spain
Contact: Antoni Torres, MD, PhD         
Principal Investigator: Antoni Torres, MD, PhD.         
Sub-Investigator: Juan Ramón Badía, MD, PhD         
Hospital Universitario de la Princesa Recruiting
Madrid, Spain, 28006
Contact: Antonio Reyes, MD., PhD.    34-91-520-2200    Areyes.hlpr@salud.madrid.org   
Contact: Fernando Lopez, MD., PhD.    34-91-520-2200    fld@inicia.es   
Principal Investigator: Antonio Reyes, MD., PhD.         
Sub-Investigator: Fernando - Lopez, MD, PhD         
Francisco Ortuño Anderiz Recruiting
Madrid, Spain, 28040
Contact: Francisco - Ortuño Anderiz, MD    34-91-330-3223    portunoa@yahoo.es   
Sub-Investigator: Fernando - Martinez Sagasti, MD, PhD         
Clinica Moncloa Recruiting
Madrid, Spain
Contact: Manuel Alvarez, MD, PhD.         
Contact: Juan Jose Oñoro, MD         
Principal Investigator: Manuel Alvarez, MD, PhD         
María Mar Cruz Acuaroni Recruiting
Toledo, Spain, 45004
Contact: Maria Mar - Cruz Acuaroni, MD    34-925-26-9237    mdelca@sescam.jccm.es   
Contact: Maria José - Pérez Pedrero, MD    34-925-26-9237      
Principal Investigator: Maria Mar - Cruz Acuaroni, MD         
Sub-Investigator: Maria Jose - Perez Pedrero, MD         
Sponsors and Collaborators
Hospital Universitario Principe de Asturias
Pfizer
Investigators
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Study Chair: Miguel Sanchez, MD, PhD Hosp. Univ. Principe de Asturias
More Information
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Publications:

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Responsible Party: Miguel Sanchez Garcia, MD, PhD, Hospital Principe de Asturias
ClinicalTrials.gov Identifier: NCT00127985     History of Changes
Other Study ID Numbers: NAIF6MPMODS088UNK9071296
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: May 13, 2008
Last Verified: May 2008
Keywords provided by Hospital Universitario Principe de Asturias:
multiple organ dysfunction syndrome
corticosteroids
mortality
Additional relevant MeSH terms:
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Syndrome
Multiple Organ Failure
Disease
Pathologic Processes
Shock
Prednisolone
Methylprednisolone Acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
 Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents