Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock

NCT ID: NCT01858909

Last Updated: 2013-05-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2013-12-31

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.

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).

Conditions

Severe Sepsis; Septic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control

saline every 12 hours for 28 days

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Melatonin

Oral 30mg/12hours melatonin 28 days

Group Type: EXPERIMENTAL

Melatonin

Intervention Type: DRUG

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

Interventions

Melatonin

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

Intervention Type: DRUG

Other Intervention Names

Liquid 1 mg/mL Melatonin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Sanidad, Servicios Sociales e Igualdad

OTHER_GOV

Sponsor Role: collaborator

Aragon Institute of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francisco A García-Gil, Physician

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Lozano Blesa

Locations

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, Spain

Countries

Spain

Other Identifiers

TRA-172

Identifier Type: -

Identifier Source: org_study_id