Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
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|ClinicalTrials.gov Identifier: NCT01858909|
Recruitment Status : Unknown
Verified May 2013 by Aragon Institute of Health Sciences.
Recruitment status was: Not yet recruiting
First Posted : May 21, 2013
Last Update Posted : May 21, 2013
OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock.
- 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.
To evaluate, waiting for reduction under the influence of the treatment with melatonin, :
- clinical - analytical parameters of sepsis;
- levels of cytokines;
- oxidative and nitrosative stress;
- acute-phase proteins (APP), specially of the ITIH4;
- immune response;
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis Septic Shock||Drug: Melatonin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Phase III, Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock|
|Study Start Date :||May 2013|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2013|
Placebo Comparator: Control
saline every 12 hours for 28 days
Oral 30mg/12hours melatonin 28 days
Administration via oral or via a nasogastric tube followed by 20mL saline
Other Name: Liquid 1 mg/mL Melatonin
- Mortality [ Time Frame: 1 month ]Mortality at 28 days of study entry.
- Clinical evolution parameters [ Time Frame: 1 month ]Days of mechanical ventilation. Days with vasoactive drugs. Days with hemodialysis or hemofiltration. Superinfection of organs other than the initial cause of the sepsis. Progression to other organs fail after starting the treatment.
- Clinical evolution [ Time Frame: 1 month ]clinical - analytical parameters relative to the sepsis
- Oxidative-nitrosative parameters [ Time Frame: 1 month ]Melatonin plasmatic levels Quantification of malonyldialdehyde and 4-hydroxynonenal Protein carbonyl content Nitrites Erythrocyte membrane fluidity Superoxide dismutase, catalase, glutathione reductase and glutathione peroxidase activity
- Inflammatory parameters [ Time Frame: 1 month ]Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF
- Acute phase proteins [ Time Frame: 1 month ]PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4
- Immune parameters [ Time Frame: 1 month ]Lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins
- Endocrine parameters [ Time Frame: 1 month ]Cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01858909
|Hospital Clínico Universitario Lozano Blesa|
|Zaragoza, Spain, 50009|
|Principal Investigator:||Francisco A García-Gil, Physician||Hospital Clínico Universitario Lozano Blesa|