Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
Status:
Unknown status
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with
severe sepsis and septic shock.
Specifically:
1. To evaluate the survival to 28 days of mechanical assisted ventilation, days with
vasoactive drugs, need of hemodialysis-hemofiltration, superinfection and evolution
towards the failure of other organs.
2. To evaluate, waiting for reduction under the influence of the treatment with melatonin,
:
1. clinical - analytical parameters of sepsis;
2. levels of cytokines;
3. oxidative and nitrosative stress;
4. acute-phase proteins (APP), specially of the ITIH4;
5. immune response;
6. endocrine response.
METHODOLOGY. Patients will be randomized in two groups, n = 55 in each group: 1) treatment
with melatonin 30mg/12 hours 28 days; 2) placebo.
Determinations: a) clinical - analytical parameters relative to the sepsis; b) melatonin
plasmatic levels; c) quantification of malonyldialdehyde and 4-hydroxynonenal, protein
carbonyl content, nitrites, erythrocyte membrane fluidity, and superoxide dismutase,
catalase, glutathione reductase and glutathione peroxidase activity; d) Interleukins-1,2,4,5,
6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF; e) acute-phase proteins: PCR, haptoglobin, Apo A-I,
α1-GPA and ITIH4; f) lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins; g)
cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3. Data will be
analyzed following a prospectively define plan and by intention-to-treat (ITT) analysis.
Phase:
Phase 3
Details
Lead Sponsor:
Aragon Institute of Health Sciences
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad