- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07302737
Delirium och hjärtsvikt
Noggrannheten hos olika biomarkörer för att förutsäga delirium hos äldre vuxna med hjärtsvikt
Biomarkers such as Systemic Immune-Inflammation Index (SII) and TG/Glucose Ratio (TyG) have shown promise in predicting delirium, reflecting the roles of inflammation and metabolic disturbances in its pathophysiology. This study aims to compare the predictive value of SII and the TyG ratio among other chemical and physiological biomarkers for diagnosing delirium and detecting its severity in older adults with heart failure. These biomarkers reflect different pathophysiological pathways implicated in delirium, including inflammation, cardiovascular stress, and metabolic dysfunction. By evaluating their individual and combined predictive abilities, this research seeks to identify potential tools for early identification of patients at high risk for delirium
Studieöversikt
Status
Betingelser
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
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Cairo, Egypten, 11566
- Ain Shams University hospitals
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
hospitalized older adults with heart failure
Beskrivning
Inclusion Criteria:
Heart failure stage C
Exclusion Criteria:
- cognitive impairment
- Major Neurological Conditions: (e.g., stroke, traumatic brain injury).
- Hematological diseases that affect platelet, neutrophil, and lymphocyte counts.
- Cardiogenic Shock
- Sepsis
- Ongoing Treatment with Immunosuppressants, or corticosteroids
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
cases
hospitalized older patients with heart failure and delirium |
multidimensional assessment of cognition, physical, function, mood, social status of the participants standardized tool designed to quickly and accurately diagnose delirium by assessing four key features: acute mental change, inattention, and either disorganized thinking or altered consciousness. The original CAM is used for communicative patients on general wards, relying on conversation, while the CAM-ICU is adapted for critically ill, often non-verbal patients in the ICU, using non-verbal tasks and sedation scales. By providing a rapid, reliable method for identifying this often-missed condition, both tools trigger crucial medical interventions, helping to mitigate delirium's serious risks, including longer hospital stays, long-term cognitive decline, and increased mortality. The Delirium Rating Scale-Revised-98 (DRS-R-98) is a standardized, expert-rated clinical tool designed specifically to measure the severity of delirium and help distinguish it from other psychiatric disorders, such as dementia, depression, and schizophrenia. Unlike the CAM/CAM-ICU, which provides a simple "yes/no" diagnosis, the DRS-R-98 quantifies how severe a patient's delirium is at a given point in time and tracks changes in that severity over the course of the illness complete blood count(to obtain systemic inflammatory index) ,triglyceride (TG) and glucose, Liver and kidney function tests and serum electrolytes level |
|
controls
age and gender matched heart failure older patients without delirium |
multidimensional assessment of cognition, physical, function, mood, social status of the participants standardized tool designed to quickly and accurately diagnose delirium by assessing four key features: acute mental change, inattention, and either disorganized thinking or altered consciousness. The original CAM is used for communicative patients on general wards, relying on conversation, while the CAM-ICU is adapted for critically ill, often non-verbal patients in the ICU, using non-verbal tasks and sedation scales. By providing a rapid, reliable method for identifying this often-missed condition, both tools trigger crucial medical interventions, helping to mitigate delirium's serious risks, including longer hospital stays, long-term cognitive decline, and increased mortality. complete blood count(to obtain systemic inflammatory index) ,triglyceride (TG) and glucose, Liver and kidney function tests and serum electrolytes level |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
the sensitivity and specificity of different biomarkers of delirium in heart failure older patient
Tidsram: Within 24 hours of hospital admission
|
assess sensitivity and specificity of the systemic inflammatory index (SII), Rate Pressure Product (RPP), and TG/glucose ratio in predicting delirium |
Within 24 hours of hospital admission
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
in hospital morbidity
Tidsram: From enrollment to the hospital discharge about 6 weeks
|
follow up cohort for possible complications like acute kidney injury, infections, or adverse drug events |
From enrollment to the hospital discharge about 6 weeks
|
|
In hospital mortality
Tidsram: From enrollment to hospital discharge about 6 weeks
|
cohort follow up throughout hospital course and mortality recorded |
From enrollment to hospital discharge about 6 weeks
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neurologiska manifestationer
- Sjukdomar i nervsystemet
- Hjärt-kärlsjukdomar
- Mentala störningar
- Hjärtsjukdom
- Neurobehavioral manifestationer
- Neurokognitiva störningar
- Patologiska tillstånd, tecken och symtom
- Tecken och symtom
- Hjärtsvikt
- Delirium
- Förvirring
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Epidemiologiska metoder
- Datainsamling
- Hälsovårdsutvärderingsmekanismer
- Hälsovårdskvalitet
- Folkhälsa
- Miljö och folkhälsa
- Befolkningsegenskaper
- Hälsostatus
- Demografi
- Epidemiologiska mätningar
- Geriatrisk bedömning
Andra studie-ID-nummer
- FMASU MD195/2025
Plan för individuella deltagardata (IPD)
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