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Not yet recruitingNCT06156059Mel-ICUUpdated Mar 1, 2024

Oral Bedtime Melatonin in Critically Ill Patients

A Phase 4 interventional study of Oral Bedtime Melatonin and Placebo suspension or capsule in Septic Shock, Stroke Hemorrhagic and Strokes Thrombotic, sponsored by Hospital San Carlos, Madrid. Not yet recruiting. Per ClinicalTrials.gov, last updated 2024-03-01.

Sponsored by Hospital San Carlos, Madrid · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Phase 4
Study type
Interventional
Enrollment
160
Allocation
Randomized
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Septic Shock
  • Stroke Hemorrhagic
  • Strokes Thrombotic
  • Cardiac Arrest
03

In context

Shock, Septic

1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.

This study's planned enrollment of 160 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.

Browse Shock, Septic studies →

Lead sponsor

Hospital San Carlos, Madrid is the lead sponsor of 74 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ICU stay >5 days

Exclusion criteria

Exclusion Criteria:

  • ominous prognosis
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Placebo comparator
    Septic Shock Standard of Care (SOC)

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule

  • Active comparator
    Septic shock Oral Bedtime Melatonin (OBM)

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin

  • Placebo comparator
    Resuscitated Cardiorespiratory Arrest SOC

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule

  • Active comparator
    Resuscitated Cardiorespiratory Arrest OBM

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin

  • Placebo comparator
    Ischemic Stroke (SOC)

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule

  • Active comparator
    Ischemic stroke (OBM)

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin

  • Placebo comparator
    Hemorraghic stroke (SOC)

    Placebo suspension and capsules

    Drug: Placebo suspension or capsule

  • Active comparator
    Hemorrhagic stroke (OBM)

    100 mg suspension or in capsules OBM

    Drug: Oral Bedtime Melatonin

Interventions

  • DrugOral Bedtime Melatonin

    100 mg oral suspension or capsule given at bedtime

    Also known as: Oral melatonin

  • DrugPlacebo suspension or capsule

    Indistinguishable suspension or capsule

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Mortality at 90 days

    All-cause mortality

    Time frame: Inclusion to 90 days

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Feb 2025; primary completion for Feb 2026, 12 months later.

Of 39 non-industry phase 4 interventional studies under Shock, Septic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 38. This study's planned 12 months is below that.

Counting every sponsor, half of 40 studies reached it within 24 months; a quarter within 16 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 26, 2023
First posted
Dec 5, 2023
StartEst.
Feb 1, 2025
Primary completionEst.
Feb 1, 2026
CompletionEst.
Apr 1, 2026
Last update
Mar 1, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 1, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06156059
Lead sponsor
Hospital San Carlos, Madrid
Collaborators
Universidad Complutense de Madrid
Responsible party
Miguel Sanchez Garcia (Director Critical Care Department, Hospital San Carlos, Madrid) — Principal investigator
First posted
Dec 5, 2023
Start date
Feb 1, 2025 (estimated)
Primary completion
Feb 1, 2026 (estimated)
Completion
Apr 1, 2026 (estimated)
Last update
Mar 1, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Melatonin

Other studies in this condition

Shock, Septic →

Other studies from this sponsor

Hospital San Carlos, Madrid

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