Delirium and Heart Failure

NCT ID: NCT07302737

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-20

Study Completion Date

2026-08-01

Brief Summary

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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

Detailed Description

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Conditions

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Delirium Confusional State Heart Failure

Keywords

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Heart failure delirium older adults

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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cases

hospitalized older patients with heart failure and delirium

Comprehensive Geriatric Assessment

Intervention Type OTHER

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

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

Intervention Type 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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

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

Comprehensive Geriatric Assessment

Intervention Type OTHER

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

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

Intervention Type 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.

blood biomarkers

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Comprehensive Geriatric Assessment

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

Intervention Type 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 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.

Intervention Type 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

Intervention Type OTHER

blood biomarkers

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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Doha Rasheedy, Professor

Role: primary

Other Identifiers

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FMASU MD195/2025

Identifier Type: -

Identifier Source: org_study_id