Trials Sponsors Conditions Drugs Pricing

Conditions

Critically Ill Patients Mechanically Ventilated Patients

Keywords

melatoninactigraphysedationcritical patientsICU

Outcome Measures

Primary Outcomes (1)

Overall sedatives daily doses
Discharge from ICU

Secondary Outcomes (6)

Prevalence of Delirium assessed with CAM-ICU
Discharge from ICU
Prevalence of mental disorders
60 days after ICU discharge
ICU length of stay
Discharge from ICU
ICU mortality
Discharge from ICU
Hospital mortality
Hospital discharge
+1 more secondary outcomes

Study Arms (2)

A - placebo

PLACEBO COMPARATOR

Identical tablets without the active principles. Each evening, nurses are requested to give 2 tablets at 8 PM and 12 PM

Drug: Placebo

B - melatonin

ACTIVE COMPARATOR

Identical tablets containing melatonin 3 mg Nurses are requested to give two tablets daily, at 8 PM and 12 PM.

Drug: Oral melatonin 3mg BID

Interventions

Oral melatonin 3mg BIDDrug

Identical tablets containing melatonin 3 mg. Nurses are requested to give two tablets daily, at 8 PM and 12 PM

Also known as: MELATONIN 3 mg

B - melatonin

PlaceboDrug

Identical tablets without the active principles. Each evening nurses are requested to give 2 tablets at 8 PM and 12 PM

A - placebo

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

High Treatment \> 1 day
Normal gastrointestinal function

You may not qualify if:

Sponsors & Collaborators

University of Milan
Otherlead

Study Sites (1)

Azienda Ospedaliera San Paolo - Polo Universitario

Milan, 20142, Italy

MeSH Terms

Interventions

MelatoninBID protein, human

Intervention Hierarchy (Ancestors)

TryptaminesIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

Gaetano Iapichino, MD
University of Milan
STUDY CHAIR

Enrollment

96 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

May 4, 2007

First Posted

May 8, 2007

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

Oral Melatonin in Critically Ill High-risk Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

A - placebo

B - melatonin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

A - placebo

B - melatonin

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations