Severe SepsisPhase 3NCT01858909
Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
A Phase 3 study testing Melatonin in people with Severe Sepsis and Septic Shock, run by Aragon Institute of Health Sciences at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis, Septic Shock
- What is being tested?
- Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- May 2013to Dec 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patient with more than 24 hours from the first documentation of organ dysfunction
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Zaragoza, 50009
About this study
Official title: Phase III, Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock.
Specifically:
Read more
- 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.
- To evaluate, waiting for reduction under the influence of the treatment with melatonin, :
- clinical - analytical parameters of sepsis;
- levels of cytokines;
- oxidative and nitrosative stress;
- acute-phase proteins (APP), specially of the ITIH4;
- immune response;
- 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.
Read the 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
- Being tested
- Melatonin
- Keywords
- Sepsis
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Liquid 1 mg/mL Melatonin
Administration via oral or via a nasogastric tube followed by 20mL saline
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | saline every 12 hours for 28 days |
| Melatonin | Experimental | Oral 30mg/12hours melatonin 28 days Receives: Drug: Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Mortality at 28 days of study entry.
Measured: 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.
Measured: 1 month
Secondary outcomes (6)
Clinical evolution
clinical - analytical parameters relative to the sepsis
Measured: 1 month
Oxidative-nitrosative parameters
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
Measured: 1 month
Inflammatory parameters
Interleukins-1,2,4,5, 6, 7,8,10,12,13, IFN-γ; TNF-α and GM-CSF
Measured: 1 month
Acute phase proteins
PCR, haptoglobin, Apo A-I, α1-GPA and ITIH4
Measured: 1 month
Immune parameters
Lymphocytes T, B, NK, T CD4, and T CD8, and immunoglobulins
Measured: 1 month
Endocrine parameters
Cortisol, aldosterone, ACTH, ADH, insulin, glucagon and 25-hydroxyvitamin D3
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aragon Institute of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Responsible party
- Sponsor
- Investigators
- Francisco A García-Gil, Physician, Principal investigator, Hospital Clínico Universitario Lozano Blesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01858909
- Sponsor's protocol ID
- TRA-172
- Status last verified
- May 2013
- First submitted
- 17 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III, Prospective, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Melatonin in Patients With Severe Sepsis or Septic Shock
- ClinicalTrials.gov ID
- NCT01858909
- Acronym / sponsor ID
- TRA-172
- Conditions
- Severe Sepsis, Septic Shock
- Keywords
- Sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Aragon Institute of Health SciencesUniversity, hospital or other
- Collaborators
- Ministerio de Sanidad, Servicios Sociales e Igualdad
- Study start
- May 2013
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES. To establish the therapeutic efficiency of melatonin in adult patients with severe sepsis and septic shock.
Specifically:
- 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.
- To evaluate, waiting for reduction under the influence of the treatment with melatonin, :
- clinical - analytical parameters of sepsis;
- levels of cytokines;
- oxidative and nitrosative stress;
- acute-phase proteins (APP), specially of the ITIH4;
- immune response;
- 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | –saline every 12 hours for 28 days |
| Melatonin | Experimental | Drug: MelatoninOral 30mg/12hours melatonin 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patient with more than 24 hours from the first documentation of organ dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MelatoninAlso: Liquid 1 mg/mL MelatoninAdministration via oral or via a nasogastric tube followed by 20mL saline | Drug | Melatonin |
Primary outcome
Mortality
Time frame: 1 month
Mortality at 28 days of study entry.
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.
6 secondary outcomes
Clinical evolution
Time frame: 1 month
Oxidative-nitrosative parameters
Time frame: 1 month
Inflammatory parameters
Time frame: 1 month
Acute phase proteins
Time frame: 1 month
Immune parameters
Time frame: 1 month
Endocrine parameters
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francisco A García-Gil, Physician principal investigator
Hospital Clínico Universitario Lozano Blesa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Melatonin in people with Severe Sepsis and Septic Shock, run by Aragon Institute of Health Sciences at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013; AzTrials last refreshed its copy on 8 Nov 2026.