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Sponsors and Collaborators: |
Hospital Principe de Asturias Pfizer |
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Information provided by: | Hospital Principe de Asturias |
ClinicalTrials.gov Identifier: | NCT00127985 |
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:
Condition | Intervention | Phase |
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Multiple Organ Dysfunction Syndrome |
Drug: 6-methyl-prednisolone |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome |
Estimated Enrollment: | 240 |
Study Start Date: | August 2005 |
Estimated Study Completion Date: | July 2008 |
Estimated Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Experimental
IV 6-methyl-prednisolone
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Drug: 6-methyl-prednisolone
iv, 2 mg/kg/day, qid
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Comparator: Placebo Comparator
IV Placebo
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Drug: 6-methyl-prednisolone
iv, 2 mg/kg/day, qid
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Additional Inclusion Criteria:
Infections:
Exclusion Criteria:
Immune status and steroid therapy.
Steroid therapy
Other significant pre-existing underlying chronic diseases:
Contact: Miguel Sanchez, MD, PhD | 34-91-887-8100 ext 2205 | miguelsanchez.areachip@wanadoo.es |
Spain | |
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 | |
Spain, Madrid | |
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 |
Study Chair: | Miguel Sanchez, MD, PhD | Hosp. Univ. Principe de Asturias |
Responsible Party: | Hospital Principe de Asturias ( Miguel Sanchez Garcia, MD, PhD ) |
Study ID Numbers: | NAIF6MPMODS088UNK9071296 |
Study First Received: | August 8, 2005 |
Last Updated: | May 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00127985 |
Health Authority: | Spain: Ministry of Health |
multiple organ dysfunction syndrome corticosteroids mortality |
Shock Methylprednisolone Multiple Organ Failure Prednisolone |
Methylprednisolone acetate Prednisolone acetate Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Disease Antineoplastic Agents, Hormonal Antineoplastic Agents Physiological Effects of Drugs Gastrointestinal Agents Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Protective Agents Neuroprotective Agents |
Glucocorticoids Hormones Pharmacologic Actions Pathologic Processes Autonomic Agents Syndrome Therapeutic Uses Peripheral Nervous System Agents Central Nervous System Agents |