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Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

Primary Purpose

Delirium in Old Age

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Melatonin 5 mg
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium in Old Age

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women over 60 who enter the emergency department with a stay in the ward for more than 8 hours and who will remain hospitalized for more than 48 hours due to admission pathology.
  • Patients who agree to participate in the study by signing an informed consent (Signature by patient and / or family member).

Exclusion Criteria:

  • Patients with a history of dementia or previous neurological diseases.
  • Patients with a history of psychiatric disorder.
  • Patients diagnosed with any type of liver disease.
  • Warfarin treatment.
  • Delirium data on admission to the emergency department.
  • Patients under invasive mechanical ventilation and sedation.

Sites / Locations

  • Instituto Mexicano Del Seguro SocialRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Melatonin 5mg

Placebo

Arm Description

Melatonin 5mg, every 24 hours for 14 days

Starch based placebo, every 24 hours for 14 days

Outcomes

Primary Outcome Measures

Delirium
Diagnosis based Confusional Assessment Method Scale

Secondary Outcome Measures

Full Information

First Posted
December 3, 2019
Last Updated
December 4, 2019
Sponsor
Universidad Autonoma de San Luis Potosí
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1. Study Identification

Unique Protocol Identification Number
NCT04187807
Brief Title
Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department
Official Title
Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
May 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Autonoma de San Luis Potosí

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study evaluates the efficacy of melatonin 5mg in the prevention of Delirium in the older adults in emergency department. Half of the participants will receive melatonin 5mg and the other half will use a starch-based placebo.
Detailed Description
Melatonia is useful for the treatment of sleep disorders due to the interruption of the circadian rhythm, secondary to alterations caused by the environment. The doses of 5 to 10mg oral or sublingual can improve the quality of the sleep-wake cycle and alertness in short-term use. Mechanism of action of melatonin are: Binding to membrane receptors: MT1 and MT2 coupled to G protein - Union to nuclear receptors. - Interaction with cytosolic proteins. - Antioxidant of direct and indirect action. - Interaction with mitochondria. Melatonin circulates 80% bound to albumin and the rest in free form in plasma, 85-90% is metabolized by 6-hydroxymelatonin in the liver, which is then conjugated with sulfuric acid (70-80%) or glucuronic ( 5-3%), and is excreted in urine and feces. Melatonin and its metabolites act as catalytic antioxidants to safeguard mitochondrial electron transfer reactions, therefore, increases the efficiency of energy metabolism. Melatonin synthesis decreases significantly as age progresses and changes in the circadian cycle have been associated with accelerated aging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium in Old Age

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignament
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Melatonin 5mg
Arm Type
Experimental
Arm Description
Melatonin 5mg, every 24 hours for 14 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Starch based placebo, every 24 hours for 14 days
Intervention Type
Drug
Intervention Name(s)
Melatonin 5 mg
Other Intervention Name(s)
Cronocaps
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Delirium
Description
Diagnosis based Confusional Assessment Method Scale
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women over 60 who enter the emergency department with a stay in the ward for more than 8 hours and who will remain hospitalized for more than 48 hours due to admission pathology. Patients who agree to participate in the study by signing an informed consent (Signature by patient and / or family member). Exclusion Criteria: Patients with a history of dementia or previous neurological diseases. Patients with a history of psychiatric disorder. Patients diagnosed with any type of liver disease. Warfarin treatment. Delirium data on admission to the emergency department. Patients under invasive mechanical ventilation and sedation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fatima A Sánchez, Doctor of medicinen
Phone
4441777616
Email
alon118@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Antonio Gordillo, PhD
Phone
4448262346
Ext
6688
Email
gordillo@uaslp.mx
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonio Gordillo, PhD
Organizational Affiliation
Universidad Autonoma de San Luis Potosí
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fatima A Sánchez, Doctor of medicine
Organizational Affiliation
Universidad Autonoma de San Luis Potosí
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto Mexicano Del Seguro Social
City
San Luis Potosí
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Ruíz, Doctor of medicine
Phone
4448216363
Email
betoruizm74@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of the Administration of Melatonin 5mg in the Prevention of Delirium in Older Adults Hospitalized in the Emergency Department

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