Septic ShockPhase 4Mel-ICUNCT06156059
Oral Bedtime Melatonin in Critically Ill Patients
A Phase 4 study testing Oral Bedtime Melatonin in people with Septic Shock and Stroke Hemorrhagic, run by Hospital San Carlos, Madrid.
Trial summary
Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Septic Shock, Stroke Hemorrhagic, Strokes Thrombotic
- What is being tested?
- Oral Bedtime Melatonin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2025to 1 Apr 2026
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ICU stay >5 days
Who cannot join
- ominous prognosis
About this study
Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke.
Melatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and DNA and thus cause organ dysfunction.
In a previous study we have observed that high-dose oral bedtime melatonin (OBM) is associated with improved organ function in severe Covid-19 patients
Read the detailed description
This is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of OBM or placebo.
Interim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines.
Comparative organ dysfunction score (Sequential Organ Failure Evaluation-SOFA) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days.
For the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified Rankin score and the CVC (Glasgow) at 30 and 90 days will be compared.
- Conditions
- Septic Shock, Stroke Hemorrhagic, Strokes Thrombotic, Cardiac Arrest
- Being tested
- Oral Bedtime Melatonin, Placebo suspension or capsule
- Medical subject headings
- Shock, Septic, Hemorrhagic Stroke, Thrombotic Stroke, Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Bedtime MelatoninDrug
Also called Oral melatonin
100 mg oral suspension or capsule given at bedtime
Placebo suspension or capsuleDrug
Also called Placebo
Indistinguishable suspension or capsule
| Study group | Role | What they receive |
|---|---|---|
| Septic Shock Standard of Care (SOC) | Placebo comparator | Placebo suspension and capsules Receives: Drug: Placebo suspension or capsule |
| Septic shock Oral Bedtime Melatonin (OBM) | Active comparator | 100 mg suspension or in capsules OBM Receives: Drug: Oral Bedtime Melatonin |
| Resuscitated Cardiorespiratory Arrest SOC | Placebo comparator | Placebo suspension and capsules Receives: Drug: Placebo suspension or capsule |
| Resuscitated Cardiorespiratory Arrest OBM | Active comparator | 100 mg suspension or in capsules OBM Receives: Drug: Oral Bedtime Melatonin |
| Ischemic Stroke (SOC) | Placebo comparator | Placebo suspension and capsules Receives: Drug: Placebo suspension or capsule |
| Ischemic stroke (OBM) | Active comparator | 100 mg suspension or in capsules OBM Receives: Drug: Oral Bedtime Melatonin |
| Hemorraghic stroke (SOC) | Placebo comparator | Placebo suspension and capsules Receives: Drug: Placebo suspension or capsule |
| Hemorrhagic stroke (OBM) | Active comparator | 100 mg suspension or in capsules OBM Receives: Drug: Oral Bedtime Melatonin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality at 90 days
All-cause mortality
Measured: Inclusion to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Feb 2025 (estimated)
- Primary completion1 Feb 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- double blind randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Carlos, Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Responsible party
- Principal investigator, Miguel Sanchez Garcia, Hospital San Carlos, Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156059
- Sponsor's protocol ID
- Mel-ICU
- Acronym
- Mel-ICU
- Status last verified
- Feb 2024
- First submitted
- 26 Nov 2023
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Bedtime Melatonin in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT06156059
- Acronym / sponsor ID
- Mel-ICU / Mel-ICU
- Conditions
- Septic Shock, Stroke Hemorrhagic, Strokes Thrombotic, Cardiac Arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital San Carlos, MadridUniversity, hospital or other
- Collaborators
- Universidad Complutense de Madrid
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 1 Feb 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 5 Dec 2023 (actual)
- 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.
Oxidative stress is one of the main mechanisms causing harm in severe infection with septic shock, ischemia-reperfusion injury in resuscitated cardiac arrest and ischemic and hemorrhagic stroke.
Melatonin is a potent scavenger of the mediators of oxidative stress, oxygen and nitrogen-reactive species, which directly injure cell structures like walls and DNA and thus cause organ dysfunction.
In a previous study we have observed that high-dose oral bedtime melatonin (OBM) is associated with improved organ function in severe Covid-19 patients
Detailed description
This is a double-blind randomized, adaptive trial in the 4 indications mentioned above giving 100 mg of OBM or placebo.
Interim analyses with pre-specified stopping rules will be performed in each sub-study for specific outcome variables collected at scheduled timelines.
Comparative organ dysfunction score (Sequential Organ Failure Evaluation-SOFA) will be done at baseline, 7, 14, and 30 days and mortality evaluated at 30 and 90 days.
For the 3 study groups enrolling stroke and resuscitated cardiac arrest patients, the modified Rankin score and the CVC (Glasgow) at 30 and 90 days will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- double blind randomized
| Arm | Type | Receives |
|---|---|---|
| Septic Shock Standard of Care (SOC) | Placebo comparator | Drug: Placebo suspension or capsulePlacebo suspension and capsules |
| Septic shock Oral Bedtime Melatonin (OBM) | Active comparator | Drug: Oral Bedtime Melatonin100 mg suspension or in capsules OBM |
| Resuscitated Cardiorespiratory Arrest SOC | Placebo comparator | Drug: Placebo suspension or capsulePlacebo suspension and capsules |
| Resuscitated Cardiorespiratory Arrest OBM | Active comparator | Drug: Oral Bedtime Melatonin100 mg suspension or in capsules OBM |
| Ischemic Stroke (SOC) | Placebo comparator | Drug: Placebo suspension or capsulePlacebo suspension and capsules |
| Ischemic stroke (OBM) | Active comparator | Drug: Oral Bedtime Melatonin100 mg suspension or in capsules OBM |
| Hemorraghic stroke (SOC) | Placebo comparator | Drug: Placebo suspension or capsulePlacebo suspension and capsules |
| Hemorrhagic stroke (OBM) | Active comparator | Drug: Oral Bedtime Melatonin100 mg suspension or in capsules OBM |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- ICU stay >5 days
Key exclusion criteria (1 listed)
- ominous prognosis
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 |
|---|---|---|
| Oral Bedtime MelatoninAlso: Oral melatonin100 mg oral suspension or capsule given at bedtime | Drug | Hemorrhagic stroke (OBM), Ischemic stroke (OBM), Resuscitated Cardiorespiratory Arrest OBM, Septic shock Oral Bedtime Melatonin (OBM) |
| Placebo suspension or capsuleAlso: PlaceboIndistinguishable suspension or capsule | Drug | Hemorraghic stroke (SOC), Ischemic Stroke (SOC), Resuscitated Cardiorespiratory Arrest SOC, Septic Shock Standard of Care (SOC) |
Primary outcome
Mortality at 90 days
Time frame: Inclusion to 90 days
All-cause mortality
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
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Septic Shock
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral Bedtime Melatonin in people with Septic Shock and Stroke Hemorrhagic, run by Hospital San Carlos, Madrid.
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 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 at 90 days (time frame: Inclusion to 90 days). 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 1 Mar 2024; AzTrials last refreshed its copy on 2 Nov 2026.