Ignite Creation Date:
2024-05-06 @ 1:38 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01858909
Status:
UNKNOWN
Last Update Posted:
2013-05-21
First Post:
2013-05-17
Brief Title:
Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
Sponsor:
Aragon Institute of Health Sciences
Organization:
Aragon Institute of Health Sciences
Study Overview
Official Title:
Phase III Prospective Randomized Double-blind Clinical Trial to Evaluate the Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
Status:
UNKNOWN
Status Verified Date:
2013-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 30mg12 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-1245 6 78101213 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
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 30mg12 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-1245 6 78101213 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 ICS Aragon Institute of Health Sciences
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None