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Delirium and Heart Failure

Accuracy of Different Biomarkers for Predicting Delirium in Older Adults With Heart Failure

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07302737
Enrollment
100
Registered
2025-12-24
Start date
2026-01-20
Completion date
2026-08-01
Last updated
2025-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Delirium Confusional State

Keywords

Heart failure, delirium, older adults

Brief summary

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

Interventions

OTHERComprehensive Geriatric Assessment

multidimensional assessment of cognition, physical, function, mood, social status of the participants

OTHERthe Confusion Assessment Method (CAM test) or CAM-ICU

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.

OTHERDelirium Rating Scale - Revised-98

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

DIAGNOSTIC_TESTblood biomarkers

complete blood count(to obtain systemic inflammatory index) ,triglyceride (TG) and glucose, Liver and kidney function tests and serum electrolytes level

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Heart failure stage C

Exclusion criteria

1. cognitive impairment 2. Major Neurological Conditions: (e.g., stroke, traumatic brain injury). 3. Hematological diseases that affect platelet, neutrophil, and lymphocyte counts. 4. Cardiogenic Shock 5. Sepsis 6. Ongoing Treatment with Immunosuppressants, or corticosteroids

Design outcomes

Primary

MeasureTime frameDescription
the sensitivity and specificity of different biomarkers of delirium in heart failure older patientWithin 24 hours of hospital admissionassess sensitivity and specificity of the systemic inflammatory index (SII), Rate Pressure Product (RPP), and TG/glucose ratio in predicting delirium

Secondary

MeasureTime frameDescription
in hospital morbidityFrom enrollment to the hospital discharge about 6 weeksfollow up cohort for possible complications like acute kidney injury, infections, or adverse drug events
In hospital mortalityFrom enrollment to hospital discharge about 6 weekscohort follow up throughout hospital course and mortality recorded

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026