Prospective, randomised, double-blind study to evaluate the efficacy of treatment with melatonin in adult patients with severe sepsis or septic shock.
- Conditions
- Severe sepsis or septic shock.MedDRA version: 14.0Level: PTClassification code 10040070Term: Septic shockSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2009-017825-21-ES
- Lead Sponsor
- INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 110
a) Patient admitted to the Intensive Care Unit (ICU),
b) Aged 18 years or over.
c) Fulfils the diagnostic criteria of severe sepsis or septic shock secondary to extrahospital or intrahospital pneumonia and/or intraabdominal infection.
d) More than 24 hours has passed after recording the first organ dysfunction.
e) To be receiving the standard treatments for these conditions according to universally accepted guidelines* (Dellinger RP et al, 2008) and with the antibiotherapy protocol of our ICU.
f) Signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55
a) Absence of informed consent.
b) Patient identified as being very close to death.
c) Patient expected to die within 28 days from a medical condition that cannot be cured, such as a poorly controlled neoplasm or other terminal illness.
d) History of organ transplant.
e) Absence of concomitant intensive treatment.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method