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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
Sponsor:
Collaborator:
Ministerio de Sanidad, Servicios Sociales e Igualdad
Information provided by (Responsible Party):
Aragon Institute of Health Sciences

Brief 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.


Condition or disease Intervention/treatment Phase
Severe Sepsis Septic Shock Drug: Melatonin Phase 3

Detailed Description:
This study will be done in the Hospital Clinico Lozano Blesa (Zaragoza, Spain), promoted by the Health Science Aragon Institute and its principal investigator is F. Agustín García Gil (Surgical Service). It will start in April-May 2013 and will finish 12 months later approximately. The study sponsor is I+CS (Aragon Institute of Health Sciences).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock
Drug Information available for: Melatonin

Arm Intervention/treatment
Placebo Comparator: Control
saline every 12 hours for 28 days
Experimental: Melatonin
Oral 30mg/12hours melatonin 28 days
Drug: Melatonin
Administration via oral or via a nasogastric tube followed by 20mL saline
Other Name: Liquid 1 mg/mL Melatonin




Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 month ]
    Mortality at 28 days of study entry.

  2. 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.


Secondary Outcome Measures :
  1. Clinical evolution [ Time Frame: 1 month ]
    clinical - analytical parameters relative to the sepsis

  2. 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

  3. Inflammatory parameters [ Time Frame: 1 month ]
    Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF

  4. Acute phase proteins [ Time Frame: 1 month ]
    PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4

  5. Immune parameters [ Time Frame: 1 month ]
    Lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins

  6. Endocrine parameters [ Time Frame: 1 month ]
    Cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients (males and females) over 18 years who meet the diagnostic criteria for severe sepsis or septic shock secondary to community-acquired pneumonia or hospital and or intra-abdominal infection

Exclusion Criteria:

  • Patient with more than 24 hours from the first documentation of organ dysfunction

Information from the National Library of Medicine

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


Locations
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Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Sponsors and Collaborators
Aragon Institute of Health Sciences
Ministerio de Sanidad, Servicios Sociales e Igualdad
Investigators
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Principal Investigator: Francisco A García-Gil, Physician Hospital Clínico Universitario Lozano Blesa

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Responsible Party: Aragon Institute of Health Sciences
ClinicalTrials.gov Identifier: NCT01858909     History of Changes
Other Study ID Numbers: TRA-172
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: May 21, 2013
Last Verified: May 2013

Keywords provided by Aragon Institute of Health Sciences:
Sepsis

Additional relevant MeSH terms:
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Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants