NCT00127985

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2005

Typical duration for phase_4

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

May 13, 2008

Status Verified

May 1, 2008

Enrollment Period

2.9 years

First QC Date

August 8, 2005

Last Update Submit

May 12, 2008

Conditions

Multiple Organ Dysfunction Syndrome

Keywords

multiple organ dysfunction syndromecorticosteroidsmortality

Outcome Measures

Primary Outcomes (2)

  • All cause ICU and 28-day mortality

    28 days

  • Organ dysfunction score on days 4, 7, 14, and 28 of the protocol

    Days 4, 7, 14, and 28.

Secondary Outcomes (7)

  • Mortality

    28 days

  • Morbidity: Duration of mechanical ventilation and endotracheal intubation (also a surrogate for acute steroid myopathy)

    28 days

  • Length of ICU-stay

    28 days

  • Complications of steroid therapy

    28 days

  • Infections acquired during the protocol

    28 days

  • +2 more secondary outcomes

Study Arms (2)

Active

EXPERIMENTAL

IV 6-methyl-prednisolone

Drug: 6-methyl-prednisolone

Comparator

PLACEBO COMPARATOR

IV Placebo

Drug: 6-methyl-prednisolone

Interventions

6-methyl-prednisoloneDRUG

iv, 2 mg/kg/day, qid

ActiveComparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Written informed consent to participate in the trial signed by next of kin or other authorized person.
  • Main cause or disease at admission: Adequate "source control" is required and refers to optimal, complete, and definitive surgical and/or medical therapy.
  • Infections:
  • 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.
  • Supportive Care: Optimal hemodynamic, renal, hematologic, nutritional "supportive care" is provided.

You may not qualify if:

  • Decision not to provide full support.
  • Immune status and steroid therapy.
  • 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).
  • Other immune-suppressive therapy within the previous 6 months.
  • Known AIDS.
  • Neutropenia \< 500/mcl.
  • 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:
  • Severe parenchymal liver disease (Child-Pugh grade C)
  • Severe and irreversible acute or chronic central nervous system disease.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Hospital Clinic

Barcelona, Barcelona, Spain

RECRUITING

Hospital Principe de Asturias

Alcalá de Henares, Madrid, 28805, Spain

RECRUITING

Hospital Universitario de la Princesa

Madrid, Madrid, 28006, Spain

RECRUITING

Francisco Ortuño Anderiz

Madrid, Madrid, 28040, Spain

RECRUITING

Clinica Moncloa

Madrid, Madrid, Spain

RECRUITING

María Mar Cruz Acuaroni

Toledo, Toledo, 45004, Spain

RECRUITING

Related Publications (2)

  • Meduri GU, Headley AS, Golden E, Carson SJ, Umberger RA, Kelso T, Tolley EA. Effect of prolonged methylprednisolone therapy in unresolving acute respiratory distress syndrome: a randomized controlled trial. JAMA. 1998 Jul 8;280(2):159-65. doi: 10.1001/jama.280.2.159.

    PMID: 9669790BACKGROUND

  • Marshall JC, Cook DJ, Christou NV, Bernard GR, Sprung CL, Sibbald WJ. Multiple organ dysfunction score: a reliable descriptor of a complex clinical outcome. Crit Care Med. 1995 Oct;23(10):1638-52. doi: 10.1097/00003246-199510000-00007.

    PMID: 7587228BACKGROUND

MeSH Terms

Conditions

Multiple Organ Failure

Interventions

methyl 11,17,21-trihydroxy-3,20-dioxopregna-1,4-diene-16-carboxylate

Condition Hierarchy (Ancestors)

ShockPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Miguel Sanchez, MD, PhD

    Hosp. Univ. Principe de Asturias

    STUDY CHAIR

Central Study Contacts

Miguel Sanchez, MD, PhD

CONTACT

34-91-887-8100miguelsanchez.areachip@wanadoo.es

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

August 1, 2005

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

May 13, 2008

Record last verified: 2008-05

Locations

ES(6)