Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Melatonin for Prevention of Post- Operative Delirium Pilot Study Protocol

15. september 2016 oppdatert av: Muralidhara Rao, Loyola University

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.

Studieoversikt

Status

Tilbaketrukket

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Surgery causes oxidative stress on the brain9 leading to inflammation. Post-operative delirium has been linked with inflammation in the brain. Delirium has been hypothesized to be a central nervous system response to systemic inflammation during a state of blood-brain barrier (BBB) compromise.

Studies have shown a rise of inflammatory cytokines and fall of anti-inflammatory cytokines. Vice-versa, external cytokine administration has been shown to lead to delirium. Melatonin is known for its strong anti-oxidant and anti-inflammatory properties, this should account for its preventive properties in post-operative delirium. It has also been hypothesized that post-operative delirium in elderly is caused by circadian rhythm disturbances secondary to a relative lack of melatonin.

Keeping in mind the above two possible pathophysiology for delirium, investigators are expecting melatonin supplementation should be able to reduce the incidence of post-operative delirium particularly in elderly population.

Studietype

Intervensjonell

Fase

  • Fase 4

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Illinois
      • Maywood, Illinois, Forente stater, 60153
        • Loyola University Medical Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Patients 65 years of age and older undergoing Low Energy Lower Extremity Fractures (LELEF) surgery
  • Presence of an LELEF fracture
  • Low Energy (e.g., falls from standing height, falls from sitting, etc.).

  • Operative Fractures:

    • Pathologic femur and tibia fractures
    • Femoral neck fractures
    • Pertroch: including intertroch, subtroch fractures
    • Femoral shaft
    • Supracondylar femur fractures
    • Periprosthetic fractures around total hip and total knee arthroplasties
    • Tibial plateau fractures
    • Proximal Tibia Fractures
    • Tibial Shaft Fractures
    • Distal 1/3 tibia fractures
    • Ankle Fractures that are admitted

Exclusion Criteria:

  • Patients with previous adverse reaction or side-effects to melatonin
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
  • Inability to communicate in English
  • Patients with a Montreal Cognitive Assessment (MoCA) score of below 7 will not be included in the study because of their inability to give informed consent at that stage. This score is approximately 2 standard deviation below average score for Alzheimer's Dementia.
  • Participants who are unable to give consent or communicate well in English will not be enrolled

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Placebo
Individuals who are randomized to the control arm will receive liquid placebo sublingually 60-90 minutes prior to surgery.
Legemiddel: Placebo
10 mg liquid placebo at 7 pm for 1 week
Aktiv komparator: Melatonin
Individuals who are randomized to the treatment arm will receive 10 mg liquid IR-SL melatonin 60-90 minutes prior to surgery
Legemiddel: Melatonin
10 mg liquid Melatonin IR-SL at 7 pm for 1 week

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Delirium assessment
Tidsramme: 1 Week
The Delirium Rating Scale Revised (DRS-R98) will be given to all patients every day for seven days. Investigators will compare the scores recorded on day 7 between those receiving melatonin versus those receiving placebo controlling for their baseline performance.
1 Week

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hospital stay
Tidsramme: 1 Week
Length of hospital stay will be recorded for all patients and compared between the two treatment groups (i.e., those receiving melatonin and those receiving placebo).
1 Week

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Loyola University

Etterforskere

  • Hovedetterforsker: Muralidhara S Rao, MD, Loyola University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2015

Primær fullføring (Forventet)

1. juni 2018

Studiet fullført (Forventet)

1. juni 2018

Datoer for studieregistrering

Først innsendt

13. september 2016

Først innsendt som oppfylte QC-kriteriene

15. september 2016

Først lagt ut (Anslag)

16. september 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

16. september 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2016

Sist bekreftet

1. september 2016

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 206981

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere