6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00127985
• Date of registration: 08/08/2005
• Primary sponsor: Hospital Universitario Principe de Asturias
• Public title: 6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome NAIF
• Scientific title: The Effect of 6-Methyl-Prednisolone on Organ Dysfunction and Mortality of Patients With Unresolving Multiple Organ Dysfunction Syndrome
• Date of first enrolment: August 2005
• Target sample size: 240
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00127985
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Miguel Sanchez, MD, PhD

• Name: Miguel Sanchez, MD, PhD
• Affiliation: Hosp. Univ. Principe de Asturias

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Multiple Organ Dysfunction Syndrome

Intervention(s)

Drug: 6-methyl-prednisolone

Primary Outcome(s)

All cause ICU and 28-day mortality [Time Frame: 28 days]

Organ dysfunction score on days 4, 7, 14, and 28 of the protocol [Time Frame: Days 4, 7, 14, and 28.]

Secondary Outcome(s)

Adrenal reserve as evaluated by adrenocorticotropic hormone (ACTH) test. [Time Frame: Baseline]

Complications of steroid therapy [Time Frame: 28 days]

Infections acquired during the protocol [Time Frame: 28 days]

Length of ICU-stay [Time Frame: 28 days]

Morbidity: Duration of mechanical ventilation and endotracheal intubation (also a surrogate for acute steroid myopathy) [Time Frame: 28 days]

Mortality [Time Frame: 28 days]

Other complications (hyperglycemia, GI bleeding, acute myopathy, pneumothorax) [Time Frame: 28 days]

Secondary ID(s)

NAIF6MPMODS088UNK9071296

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer