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Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock

NCT01858909 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2013-05-21

No results posted yet for this study

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.

Conditions

  • Severe Sepsis
  • Septic Shock

Interventions

DRUG

Melatonin

Administration via oral or via a nasogastric tube followed by 20mL saline

Sponsors & Collaborators

  • Ministerio de Sanidad, Servicios Sociales e Igualdad

    collaborator OTHER_GOV

  • Aragon Institute of Health Sciences

    lead OTHER

Principal Investigators

  • Francisco A García-Gil, Physician · Hospital Clínico Universitario Lozano Blesa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01858909 on ClinicalTrials.gov