6-Methyl-Prednisolone for Multiple Organ Dysfunction Syndrome (NAIF)
Recruitment status was: Recruiting
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).
- All cause Intensive Care Unit (ICU) and 28-day mortality
- Organ dysfunction score on days 4, 7, 14, and 28 of the protocol.
Multiple Organ Dysfunction Syndrome
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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|
- All cause ICU and 28-day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Organ dysfunction score on days 4, 7, 14, and 28 of the protocol [ Time Frame: Days 4, 7, 14, and 28. ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Morbidity: Duration of mechanical ventilation and endotracheal intubation (also a surrogate for acute steroid myopathy) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Length of ICU-stay [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Complications of steroid therapy [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Infections acquired during the protocol [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Other complications (hyperglycemia, GI bleeding, acute myopathy, pneumothorax) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
- Adrenal reserve as evaluated by adrenocorticotropic hormone (ACTH) test. [ Time Frame: Baseline ] [ Designated as safety issue: No ]
|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)|
iv, 2 mg/kg/day, qid
Placebo Comparator: Comparator
iv, 2 mg/kg/day, qid
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127985
|Hospital Principe de Asturias|
|Alcala de Henares, Madrid, Spain, 28805|
|Hospital Universitario de la Princesa|
|Madrid, Spain, 28006|
|Francisco Ortuño Anderiz|
|Madrid, Spain, 28040|
|María Mar Cruz Acuaroni|
|Toledo, Spain, 45004|
|Study Chair:||Miguel Sanchez, MD, PhD||Hosp. Univ. Principe de Asturias|