Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock

NCT01858909 | Unknown Phase 3 DMC

• 1 other identifier: TRA-172
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock. Specifically:

1. 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. 2.To evaluate, waiting for reduction under the influence of the treatment with melatonin, :
3. 3.clinical - analytical parameters of sepsis;
4. 4.levels of cytokines;
5. 5.oxidative and nitrosative stress;
6. 6.acute-phase proteins (APP), specially of the ITIH4;
7. 7.immune response;
8. 8.endocrine response.

Conditions

Severe Sepsis; Septic Shock

Keywords

Sepsis

Outcome Measures

Primary Outcomes (2)

• Mortality

  Mortality at 28 days of study entry.

  1 month

• Clinical evolution parameters

  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.

  1 month

Secondary Outcomes (6)

• Clinical evolution

  1 month

• Oxidative-nitrosative parameters

  1 month

• Inflammatory parameters

  1 month

• Acute phase proteins

  1 month

• Immune parameters

  1 month

Study Arms (2)

Control

PLACEBO COMPARATOR

saline every 12 hours for 28 days

Melatonin

EXPERIMENTAL

Oral 30mg/12hours melatonin 28 days

Drug: Melatonin

Interventions

Melatonin DRUG

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

Also known as: Liquid 1 mg/mL Melatonin

Melatonin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Aragon Institute of Health Sciences: lead
• Ministerio de Sanidad, Servicios Sociales e Igualdad: collaborator

Study Sites (1)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Melatonin; Fluid Therapy

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Drug Therapy; Therapeutics

Study Officials

• Francisco A García-Gil, Physician

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2013
• First Posted: May 21, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: May 21, 2013

Record last verified: 2013-05

Locations

ES (1)