Delirium and Heart Failure

NCT07302737 | Not Yet Recruiting DMC

• 1 other identifier: FMASU MD195/2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Delirium Confusional State; Heart Failure

Keywords

Heart failure; delirium; older adults

Outcome Measures

Primary Outcomes (1)

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

  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

Secondary Outcomes (2)

• in hospital morbidity

  From enrollment to the hospital discharge about 6 weeks

• In hospital mortality

  From enrollment to hospital discharge about 6 weeks

Study Arms (2)

cases

hospitalized older patients with heart failure and delirium

Other: Comprehensive Geriatric Assessment; Other: the Confusion Assessment Method (CAM test) or CAM-ICU; Other: Delirium Rating Scale - Revised-98; Diagnostic Test: blood biomarkers

controls

age and gender matched heart failure older patients without delirium

Other: Comprehensive Geriatric Assessment; Other: the Confusion Assessment Method (CAM test) or CAM-ICU; Diagnostic Test: blood biomarkers

Interventions

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.

cases; controls

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

cases; controls

Comprehensive Geriatric Assessment OTHER

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

cases; controls

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

cases

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

hospitalized older adults with heart failure

You may qualify if:

• Heart failure stage C

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, 11566, Egypt

Location

MeSH Terms

Conditions

Heart Failure; Confusion; Delirium

Interventions

Geriatric Assessment

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Status; Demography; Population Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 24, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-11

Locations

EG (1)