Severe sepsis or septic shock. MedDRA version: 14.0 Level: PT Classification code 10040070 Term: Septic shock System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Melatonina
Product Code: Melatonina
Pharmaceutical Form: Oral solution
INN or Proposed INN: MELATONINA
Other descriptive name: MELATONINA
Concentration unit: mg/ml milligram(s)/millilitr
Sponsors
INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): -Mortality (any cause) within 28 days of inclusion in the study. The primary cause of death will be defined: multi-organic failure induced by sepsis, respiratory failure, refractory septic shock and other causes. -Clinical parameters: number of days with assisted mechanical ventilation, number of days with vasoactive drugs, need of hemodyalisis or hemofiltration and number of days, other organs infection that are not the initial cause of the septic symptoms and development of failure of other organs after starting treatment. ;Timepoint(s) of evaluation of this end point: - Mortality: 28 days after patient inclusion in the study. - Clinical parameters of patient evolution: continously within the 28 days of patient follow-up.;Main Objective: To assess the therapeutic efficacy of Melatonin in adult patients with severe sepsis and septic shock.;Secondary Objective: a)To assess severe sepsis and septic shock under the influence of Melatonin treatment: b)Analytical parameters related to sepsis. c)Behavior from the circulating levels of pro- and anti-inflammatory cytokines. d)Oxidative and Nitrosative Stress. e)Acute phase response as a marker of the intensity of the systemic inflammatory response. Mainly interested in assessing the dynamic response of ITIH4 protein (Inter-Alpha-Trypsin Inhibitor Heavy Chain 4), a positive acute phase protein IL-6 dependent, as a pioneer study, in severe sepsis treated with Melatonin. f)Celular and humoral immune response. g)Endocrine response. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluated by the response rate of: -patient clinical parameters: temperature; heart and respiratory rate; blood pressure; diuresis. -Blood parameters related to sepsis: leucocytes; platelets; bilirubinemia; glycemia; creatinine; lactacemia; arterial gasometry; coagulation study: prothrombine activity, INR (International Normalized Ratio), partial thromboplastine time, fibrinogen, Oxidative and Nitrosative Stress markers: malonaldehyde and hydroxyl-alkenals, proteins carbonyls, antioxidant serum total activity, superoxide dismutase activity, catalase, glutathione reductase and glutathione peroxidase, nitrites concentration, erythrocytes membrane fluidity and plasmatic leveles of melatonin -citokines : interleukines (IL)-1ß; IL-2; IL-4; IL-5; IL-6; IL-7; IL-8; IL-10; IL-12p70; IL-13 ; intereferon alpha; tumor necrosis factor (TNF)-a and granulocyte-macrophage colony stimulating factor (GM-CSF). -acute phase proteins: C reactive protein (CRP), haptoglobin, apolipoprotein A1 (Apo A1) and acid alpha 1-glycoprotein (a1-GPA) and Inter-Alpha-Trypsin Inhibitor Heavy Chain 4 (ITIH4). -humoral and cellular immune response: linfocytes T, B, NK, TCD4, y TCD8 and immunoglobulins. -hormone profile: cortisol, aldosterone, ACTH, ADH, insuline, glucagon and 25-hydroxyvitamin D3 (25-OHD3). ;Timepoint(s) of evaluation of this end point: Dentro de los 28 días de seguimiento de los pacientes, las variables secundarias se recogen en distintos momentos temporales. | — |
Countries
Spain
Contacts
Public ContactINSTITUTO ARAGONÉS DE CIENCIAS DE L
INSTITUTO ARAGONÉS DE CIENCIAS DE LA SALUD
Outcome results
None listed