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Oral Melatonin in Critically Ill High-risk Patients

NCT00470821 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2010-07-28

No results posted yet for this study

Summary

Sleep disruptions are extremely common in high-risk critically ill patients. The investigators want to analyse oral melatonin potentialities as a sedative and a free-radicals scavenger for critically ill patients, and secondarily for preventing Delirium during their ICU stay and post-traumatic stress disorders after ICU discharge.

Conditions

  • Critically Ill Patients
  • Mechanically Ventilated Patients

Interventions

DRUG

Oral melatonin 3mg BID

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

DRUG

Placebo

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

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Gaetano Iapichino, MD · University of Milan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-04-30
Completion
2010-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00470821 on ClinicalTrials.gov