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Melatonin for Prevention of Post- Operative Delirium Pilot Study Protocol

NCT02903901 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-09-16

No results posted yet for this study

Summary

To test the efficacy of melatonin compared to placebo in preventing post-operative delirium and reduction in intensity or duration of delirium in individuals 65 years of age and older who undergo orthopedic surgery after low energy lower extremity fractures (LELEF).

Biomarkers may play important roles in the detection, prediction and management of delirium especially in frail elderly individuals. Predictive biomarkers may help characterize an individual's susceptibility to delirium and thereby help specialized treatment, care and management of such individuals during their hospitalization. They may also help predict treatment response to a specific modality and help in selection of such modality. Recent studies performed in the UK and published in 2011 have measured plasma cholinesterase activity and determined that these levels were lower in patients who developed delirium compared with remaining subjects. Other studies have indicated that CRP may also have a role in delirium prediction as they have found that CRP measured on admission to an ICU had predictable changes that occurred within 24 hours that in turn were predictors of delirium. One the aims of the study is to compare the predictive and treatment response values of groups of biomarkers that have been hypothesized to be of predictive value.

Conditions

  • Delirium

Interventions

DRUG

Melatonin

10 mg liquid Melatonin IR-SL at 7 pm for 1 week

DRUG

Placebo

10 mg liquid placebo at 7 pm for 1 week

Sponsors & Collaborators

  • Loyola University

    lead OTHER

Principal Investigators

  • Muralidhara S Rao, MD · Loyola University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • United States

Study Locations

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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 NCT02903901 on ClinicalTrials.gov