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

Not yet recruiting

• Conditions: End Stage Renal Disease on Dialysis

• Registration Number: NCT07130721
• Lead Sponsor: Assiut University

Brief Summary

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-09
• Study First Submitted QC: 2025-08-16
• Last Update Submitted: 2025-08-16
• Study First Posted: 2025-08-19
• Last Update Posted: 2025-08-19
• Study Start: 2025-11-01
• Primary Completion: 2026-02-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum CRP level among hemodialysis patients	At baseline (one-time measurement)	To assess the level of serum CRP in hemodialysis patients with and without cardiovascular disease and compare values between the two groups to explore possible associations
Plasma D-dimer level among hemodialysis patients	At baseline (one-time measurement)	To assess the level of plasma D-dimer in hemodialysis patients with and without cardiovascular disease and compare values between the two groups to explore possible associations.

Secondary Outcome Measures

Name	Time	Method
Presence of cardiovascular abnormalities on ECG	At baseline (one-time measurement)	To assess cardiovascular status of hemodialysis patients using a standard 12-lead ECG and record the presence of abnormal findings

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt