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Not yet recruiting NCT07130721

Assessment of D-dimer and CRP for Cardiovascular Risk Prediction in Hemodialysis Patients

Observational End Stage Renal Disease on Dialysis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: C-Reactive Protein (CRP) Test, D-dimer Test, Electrocardiogram (ECG).
Who it may be relevant to
Registry conditions: End Stage Renal Disease on Dialysis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Blood Biomarkers (D-dimer and C-Reactive Protein) in Predicting Cardiovascular Complications Among Hemodialysis Patients: A Cross-Sectional Study

Overview

This study aims to assess whether two blood markers - C-reactive protein (CRP) and D-dimer - can help predict cardiovascular complications in patients undergoing regular hemodialysis. Cardiovascular disease is a common and serious problem in dialysis patients, and early detection is important. the study will include 100 adult patients from the Hemodialysis Unit at Assiut University Hospital. Participants will be divided into two groups: those with and those without known heart disease. Each participant will have a one-time blood test to measure CRP and D-dimer levels. In addition, an electrocardiogram (ECG) will be done once to check for signs of heart problems.

Detailed description

This cross-sectional study is designed to explore the potential role of hematologic biomarkers in predicting cardiovascular complications among patients undergoing maintenance hemodialysis. Cardiovascular disease is a leading cause of morbidity and mortality in this population, and systemic inflammation and hypercoagulability are thought to contribute significantly to adverse outcomes.

C-reactive protein (CRP) is a well-established marker of systemic inflammation, while D-dimer reflects activation of the coagulation and fibrinolytic pathways. Both biomarkers have been associated with increased cardiovascular risk in the general population, but their predictive value in hemodialysis patients remains insufficiently characterized.

A total of 100 adult patients on maintenance hemodialysis will be evaluated. The population will be stratified into two groups based on the presence or absence of clinically confirmed cardiovascular disease. Laboratory analysis will include measurement of CRP and D-dimer, and cardiovascular assessment will include a standard 12-lead ECG. Clinical and demographic data will also be collected.

Interventions

  • Diagnostic test C-Reactive Protein (CRP) Test
    Blood samples will be collected once from all participants to measure CRP levels
  • Diagnostic test D-dimer Test
    D-dimer levels will be assessed once to evaluate thrombotic risk.
  • Diagnostic test Electrocardiogram (ECG)
    A standard 12-lead ECG will be performed once per participant to assess cardiovascular status

Primary outcome measures

  • Serum CRP level among hemodialysis patients [Time frame: At baseline (one-time measurement)]
  • Plasma D-dimer level among hemodialysis patients [Time frame: At baseline (one-time measurement)]
Secondary outcome measures (1)
  • Presence of cardiovascular abnormalities on ECG [Time frame: At baseline (one-time measurement)]

Eligibility criteria

Inclusion criteria

  • Adults aged ≥18 years

On regular hemodialysis for at least 3 months

Able and willing to provide informed consent

Group I: Hemodialysis patients with no clinically documented cardiovascular disease

Group II: Hemodialysis patients with confirmed cardiovascular disease (by medical records, ECGs, echocardiography, or documented hospital admissions)

Exclusion criteria

  • Acute or recent infection (within the past 4 weeks)

Use of anticoagulant or antiplatelet therapy

Active malignancy

Autoimmune or chronic inflammatory disease

Known bleeding or thrombotic disorders

Pregnancy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Egypt · 1 center
  • Assiut University Hospital — Asyut

Identifiers

NCT: NCT07130721 · 04-2025-201318

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗