Predictors of Acute Kidney Injury in Patients With Acute Decompensated Heart Failure in Emergency

June 14, 2024 updated by: Shady Medhat Farouk, Sohag University
Acute Decompensated Heart Failure ADHF is one of the leading causes of hospitalization. ADHF is a growing global health problem affecting more than 26 million individuals worldwide Acute Kidney Injury AKI is a common event in the natural disease history of patients with Heart Failure HF, The clinical importance of the co-existence of acute cardiac and renal dysfunction, known as acute cardiorenal syndrome CRS, and its management have recieved great attention recently Various studies have employed different criteria to define and calssify AKI. According to Risk, Injury, and Failure; and Loss, and End-stage kidney disease RIFLE criteria formulated by the Acute Dialyisis Quality Initiative ADQI AKI can be divided into five stages; renal injury risk, renal impairment, renal failure, renal function loss, and end stage kidney disease

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

In the past few years, investigators have reported that AHF patients might experience "congestion", named to describe signs and symptoms of extracellular fluid accumulation that results in increased cardiac filling pressure. This triggers compensatory mechanisms such as the renin-angiotensin-aldosterone system, sympathetic nervous system, and other local mediators. These compensatory mechanisms interact to maintain fluid volume and "renal congestion" has been recognized as part of systemic congestion. Renal congestion, resulting from lower cardiac output, tubule glomerular feedback, increased intra-abdominal pressure and increased venous pressure, has been viewed as a contributor to renal function impairment in ADHF.

Most patients with acute CRS are treated in the emergency department ED. The findings provide important insight into the present situation of patients with ADHF who develop AKI in an emergency setting.

The current diagnostic paradigm for AKI relies largely on biomarkers of renal function (serum creatinine and urine output) that have been in clinical use for over 50 years but are known to be insensitive and slow to change after kidney injury . It is very important to detect kidney damage in the preclinical process with new diagnostic methods and thus to provide early intervention in AKI.

Changing AKI definition and classification by year, these existing prediction models also vary by population, region, sample size and research methods. However, many studies have found a high incidence of AKI and a large impact on outcomes in ADHF patients, data pooled from these studies are inadequate. So, we will conduct this study to evaluate predictors of AKI in patients with ADHF in emergency departments.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Aged >18 Yrs Both Sexes Patients with ADHF

Description

Inclusion Criteria:

  • Aged >18 Yrs Both Sexes Patients with ADHF

Exclusion Criteria:

  • Patients udnergoing maintenance renal replacment therapy (RRT) such as hemodialysis and peritoneal dialysis History of CKD Kdiney transplantation Undergoing opeartions within 1 week before and after AKI events Drug Toxicity Rheumatologic or auto immune disease Acute infection Diretic therapy of radio-opaque contrast media in the last 15 days History of aminoglycosides, metformin and nonsteroid anti inflammatory drugs in the last 7 days Thyroid dysfunction

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
( Patients with worsening ADHF)
Diagnostic test: Serum Creatinine
Laborataries for prediction of AKi in patients with ADHF
Other Names:
  • Lipid profile
  • CBC
  • Estimated GFR
  • Serum electrolytes
  • CKMB
  • Cardiac Troponin
Group II
(Patients with new (de novo ) ADHF)
Diagnostic test: Serum Creatinine
Laborataries for prediction of AKi in patients with ADHF
Other Names:
  • Lipid profile
  • CBC
  • Estimated GFR
  • Serum electrolytes
  • CKMB
  • Cardiac Troponin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum creatinine in mg/dL in patients with acute decompensated heart failure in ER
Time Frame: 6 months
Change in serum creatinine in patients with acute decompensated heart failure in ER
6 months

Collaborators and Investigators

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

Sponsor

Sohag University

Investigators

  • Principal Investigator: Magdy M Amin, Professor, Sohag 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 (Actual)

June 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 18, 2024

Study Record Updates

Last Update Posted (Actual)

June 18, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-24-05-17MS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

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