Ionized Calcium and Behavioural Disorders in Older Adults (CALICO Study)
28. april 2017 opdateret af: University Hospital, Angers
The primary objective of this study is to determine whether geriatric inpatients with severe behavioral disorders exhibit higher serum ionized calcium concentration than geriatric inpatients without behavioral disorders, but no difference in serum calcium or corrected calcium concentrations.
The secondary objective of this study is to determine whether the serum ionized calcium concentration is associated with behavioral and cognitive performance among geriatric inpatients.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Growing attention is paid to the neurological effects of calcium.
While calcium is necessary for neuronal physiology, it appears that high serum calcium concentrations may be toxic to neurons.
An analysis of the Rotterdam Study showed that, among older adults, higher concentrations of calcium were associated with greater cognitive disorders and faster cognitive decline.
Similarly, delirium and behavioural disorders are reported in older adults with hypercalcemia.
In contrast, other studies failed to find any association.
For example, in France, an analysis of the EPIDOS study found no association between calcium concentration and cognitive performance.
Thus, further studies remain necessary to make firmer conclusions about this link.
In particular, it is interesting to note that all previous studies have used the serum concentrations of calcium or corrected calcium, but not yet ionized calcium.
This assay is yet more reproducible, more sensitive and more correlated with clinical events.
We propose that the non-use of ionized calcium assay may explain, at least in part, the discrepancies between previous studies.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
90
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Angers, Frankrig, 49933
- Angers University Hospital
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
75 år og ældre (Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Patients are recruited in geriatric acute care.
Beskrivelse
Inclusion Criteria:
- Age 75 years and over
Cases :
- Inpatient with severe behavioural disorders
- Being hospitalized in the geriatric acute care unit of Angers University Hospital, France
Controls :
- Inpatients without severe behavioural disorder and taking no antipsychotics
- Being hospitalized in the geriatric acute care unit of Angers University Hospital, France
- Paired on age (± 3 years) and gender
Exclusion Criteria:
- Inability to understand and speak French
- Opposition to the use of information collected for this research
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Control
- Tidsperspektiver: Tværsnit
Kohorter og interventioner
Gruppe / kohorte |
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Cases
Inpatient with severe behavioural disorders
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Controls
Inpatients without severe behavioural disorder and taking no antipsychotics
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Comparison of serum ionized calcium concentrations between cases and paired controls.
Tidsramme: This outcome is assessed at baseline.
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This measurement is assessed by a blood test.
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This outcome is assessed at baseline.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Comparison of serum corrected calcium concentration between cases and paired controls.
Tidsramme: This outcome is assessed at baseline.
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This measurement is assessed by a blood test.
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This outcome is assessed at baseline.
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Comparison of the severity of behavioural disorders between cases and paired controls.
Tidsramme: This outcome is assessed at baseline.
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The severity of behavioural disorders is assessed by a standardized scale (Frontotemporal Behavioural Rating Scale (FBRS), Lebert F. et Pasquier F., 1998)
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This outcome is assessed at baseline.
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Comparison of cognitive performance between cases and paired controls.
Tidsramme: This outcome is assessed at baseline.
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Cognitive performance is assessed by the Mini-Mental State Examination (MMSE) score.
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This outcome is assessed at baseline.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2016
Primær færdiggørelse (Faktiske)
27. april 2017
Studieafslutning (Faktiske)
27. april 2017
Datoer for studieregistrering
Først indsendt
19. september 2016
Først indsendt, der opfyldte QC-kriterier
19. september 2016
Først opslået (Skøn)
21. september 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
1. maj 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. april 2017
Sidst verificeret
1. september 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-36
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
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Kliniske forsøg med Geriatriske lidelser
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Wake Forest University Health SciencesAfsluttetSelf Geriatric Assessment Measure (SGAM)Forenede Stater