Clinical Findings and Albuminuria as Predictors of Acute Kidney Injury in Patients With Acute Heart Failure

September 28, 2024 updated by: Hagar Mahmoud Hammad
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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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 <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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the predictive value of clinical examination findings as and albuminuria for AKI in ADHF patients.
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess effect of heart failure on the level of albuminuria
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hagar Mahmoud Hammad

Collaborators

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 30, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

September 28, 2024

First Submitted That Met QC Criteria

September 28, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

October 1, 2024

Last Update Submitted That Met QC Criteria

September 28, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AKI and heart failure

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe