MedTrace Logo

6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome

NCT00127985 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2008-05-13

No results posted yet for this study

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.

Conditions

  • Multiple Organ Dysfunction Syndrome

Interventions

DRUG

6-methyl-prednisolone

iv, 2 mg/kg/day, qid

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Hospital Universitario Principe de Asturias

    lead OTHER

Principal Investigators

  • Miguel Sanchez, MD, PhD · Hosp. Univ. Principe de Asturias

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127985 on ClinicalTrials.gov