Clinical trial NCT06621862: Clinical Findings and Albuminuria as Predictors of Acute Kidney Injury in Patients With Acute Heart Failure
Official title: Clinical Findings and Albuminuria as Predictors of Acute Kidney Injury in Patients With Acute Heart Failure
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Acute Kidney Injury
Albuminuria
Keywords: Heart failure
Acute Kidney Injury
Albuminuria
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Assiut University
First posted: 2024-10-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 50 patients of 18 years and older who will be admitted to the ICU with acute heart failure in Assiut University

Brief summary: assess the predictive value of clinical examination and proteinuria as early measures for acute kidney injury (AKI) in patient with acute heart failure and assessing their prognostic value as measures for mortality during hospital stay

Detailed description: Heart failure (HF) is a chronic and progressive clinical syndrome induced by structural or functional cardiac abnormalities displaying either reduced (in HF with reduced ejection fraction (HFrEF)) or preserved (in HF with preserved ejection fraction (HFpEF)) left ventricular ejection fraction (LVEF) (1).

Current guidelines define the acute decompensated heart failure (ADHF) syndrome as the presence of new or worsening signs and symptoms of HF that often lead to hospitalization or an emergency department visit for intensification of therapies (2-4). Due to population growth and ageing, the total number of HF patients continues to rise. It is estimated that 64.3 million people live with HF worldwide. In developed countries, the prevalence of known HF is generally estimated at 1-2% of the general adult population.(3, 5)

Acute kidney injury (AKI) is a frequently occurring complication of critical illness, with severe impact on morbidity and mortality. Many studies focus on advanced measures, such as biomarkers or imaging for predicting AKI. These techniques are frequently time-consuming, costly, and are not available on a global scale. In contrast, variables obtained by clinical examination are readily available without limitations by set- tings or costs. Clinical examination signs and symptoms may reflect the underlying disease state and could therefore potentially be used to identify patients at risk for AKI . In addition, a few studies have specifically focused on the role of albuminuria in predicting adverse outcomes in heart failure patients.

Eligibility criteria: Inclusion Criteria:

* All patients of 18 years and older who will be admitted to the ICU with acute heart failure (acute heart failure is defined according ESC guidelines 2021 which include Heart Failure with Reduced Ejection Fraction (HFrEF) EF \&amp;amp;lt;40% . Mid-Range Ejection Fraction (HFmrEF)(41 -46 %) , Preserved Ejection Fraction (HFpEF) EF ≥ 50%.

Exclusion Criteria:

* patients under the age of 18.

Patients with known chronic kidney disease (CKD) before ICU admission (CKD is defined as the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 mt2, persisting for 3 months or more, and or albuminuria more than 3.5 mg/mmol (12)

severe UTI

Primary outcomes:
measure: Assess the predictive value of clinical examination findings as and albuminuria for AKI in ADHF patients.
timeFrame: Baseline
Secondary outcomes:
measure: Assess effect of heart failure on the level of albuminuria
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
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