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
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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:
- All cause Intensive Care Unit (ICU) and 28-day mortality
- 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 |

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 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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:
- 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:
- 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.
- 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.
-
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.
- Severe end-stage chronic obstructive pulmonary disease (home oxygen or more than 1 exacerbation in previous year)
- 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.

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
Contact: Miguel Sanchez, MD, PhD | 34-91-887-8100 ext 2205 | miguelsanchez.areachip@wanadoo.es |
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 |
Study Chair: | Miguel Sanchez, MD, PhD | Hosp. Univ. Principe de Asturias |
Responsible Party: | Miguel Sanchez Garcia, MD, PhD, Hospital Principe de Asturias |
ClinicalTrials.gov Identifier: | NCT00127985 |
Other Study ID Numbers: |
NAIF6MPMODS088UNK9071296 |
First Posted: | August 9, 2005 Key Record Dates |
Last Update Posted: | May 13, 2008 |
Last Verified: | May 2008 |
multiple organ dysfunction syndrome corticosteroids mortality |
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 |