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Melatonin in Severe Sepsis or Septic Shock
NCT01858909Phase 3
Key facts
- Status
- Unknown
- Start
- May 2013
- Primary completion
- Dec 2013
- Countries
- 1
- Sponsor
- Instituto Aragonés de Ciencias de la Salud
- Modality
- Small Molecules
- Drugs
- melatonin
- Conditions
- sepsisseptic shock
01
Overview
Phase 3, randomised, double-blind trial of melatonin in sepsis and septic shock (2 arms), sponsored by Instituto Aragonés de Ciencias de la Salud. Primary endpoints: Mortality at 1 month and Clinical evolution parameters at 1 month. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Melatonin
Oral Melatonin 30mg every 12 hours for 28 days
Control
Placebo (saline) every 12 hours for 28 days
03
Who it enrols
Adult patients (>18 years) with severe sepsis or septic shock secondary to community-acquired pneumonia or intra-abdominal infection, with less than 24 hours of organ dysfunction.
04
Endpoints
Primary
Mortality
Clinical evolution parameters
Secondary
Oxidative-nitrosative parameters
Inflammatory parameters
Acute phase proteins
Immune parameters
Endocrine parameters
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