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Not yet recruiting NCT07302737

Delirium and Heart Failure

— Observational Heart Failure Delirium Confusional State

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Geriatric Assessment, the Confusion Assessment Method (CAM test) or CAM-ICU, Delirium Rating Scale - Revised-98, blood biomarkers.
Who it may be relevant to
Registry conditions: Heart Failure, Delirium Confusional State. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Other Comprehensive Geriatric Assessment
    multidimensional assessment of cognition, physical, function, mood, social status of the participants
  • Other the 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 condit
  • Other Delirium 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 test blood biomarkers
    complete blood count(to obtain systemic inflammatory index) ,triglyceride (TG) and glucose, Liver and kidney function tests and serum electrolytes level

Primary outcome measures

  • the sensitivity and specificity of different biomarkers of delirium in heart failure older patient [Time frame: Within 24 hours of hospital admission]
Secondary outcome measures (2)
  • in hospital morbidity [Time frame: From enrollment to the hospital discharge about 6 weeks]
  • In hospital mortality [Time frame: From enrollment to hospital discharge about 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Egypt · 1 center
  • Ain Shams University hospitals — Cairo

Identifiers

NCT: NCT07302737 · FMASU MD195/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗