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NCT Number: NCT07302737

Delirium and Heart Failure

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Confusion Delirium Delirium Confusional State Heart Diseases Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive Geriatric Assessment

Other

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

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

Other

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.

Delirium Rating Scale - Revised-98

Other

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

Blood Biomarkers

Diagnostic Test

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

Primary outcomes

  1. the sensitivity and specificity of different biomarkers of delirium in heart failure older patient

    Time frame: 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

Secondary outcomes

  1. in hospital morbidity

    Time frame: From enrollment to the hospital discharge about 6 weeks

    follow up cohort for possible complications like acute kidney injury, infections, or adverse drug events

  2. In hospital mortality

    Time frame: From enrollment to hospital discharge about 6 weeks

    cohort follow up throughout hospital course and mortality recorded

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2025
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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