Markers of Metabolism and Vascular Access in ESRD

May 2, 2023 updated by: Soad Elsayed Abu douh

Markers of Metabolism and Vascular Acess Outcomes in ESRD in[Single Centre Study]

Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come (maturation, patency of vascular access[AVF,AVG])To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Maintaining patent vascular access is essential for patients with end-stage renal disease (ESRD) on hemodialysis (HD) to prevent life-threatening technique failure. Access complications result in a high burden of hospital admissions, procedures, and costs for patients on HD.

, The pathophysiologic mechanisms underlying vascular access complications are poorly understood. Discovery of potential predictors and subsequent targets for intervention could help design new preventive strategies.Abnormalities in mineral homeostasis are common in patients with ESRD and are associated with numerous adverse outcomes including vascular calcification, inflammation, and mortality.

The Klotho gene encodes for a transmembrane protein, acting as a co-receptor for fibroblast growth factor-23 (FGF23) . The main functions of FGF23 signaling in the kidney are the suppression of vitamin D hormone synthesis, and the suppression of renal tubular phosphate reabsorption .

Impaired excretion of phosphorus due to low kidney function raises fibroblast growth factor 23 (FGF23). FGF23 decreases conversion of 25-hydroxy vitamin D (25(OH)D) to its active 1,25D form, causing calcium to fall and parathyroid hormone(PTH) to rise The development of secondary hyperparathyroidism lead to increased calcium and phosphate release from bones to the blood, causing the deposition of calcium and phosphate in the intima-media layer of arterial wall. and eventuating vascular calcification in these patients. the calcifications might be encountered in the upper extremity arteries in cases with ESRD .Thus, a decrease in the quality of fistula occurs in these tracts utilized frequently at the arteriovenous fistula (AVF) operations. Thes complex interplay of factors may promote vascular disease through multiple pathways including calcification, endothelial dysfunction, inflammation, activation of the renin-angiotensin-aldosterone system and others are involved. Deficiency of 25(OH)D among patients with ESRD is above 80%.1,25D or its analogs are frequently administered to patients with ESRD to overcome the adverse effects. low 25(OH)D associates with mortality in HD patients.

Vitamin D deficiency has been associated with hypertension, insulin resistance, viral and bacterial infection risk, and multiple organ damage due to systemic inflammation.

Despite consistent associations of disordered mineral homeostasis and vascular outcomes in ESRD, few studies have investigated the role of these factors in vascular access out comes

Study Type

Observational

Enrollment (Anticipated)

60

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Despite consistent associations of disordered mineral homeostasis and vascular outcomes in ESRD, few studies have investigated the role of these factors in vascular access outcomes.

Thes complex interplay of factors may promote vascular disease through multiple pathways including calcification, endothelial dysfunction, inflammation, activation of the renin-angiotensin-aldosterone system and others are involved(15-16),

Description

Inclusion Criteria:

  1. patient above the age of 18years old.
  2. patient on regular hemodialysis with vascular access(AVF,AVG)
  3. patient with Abnormalities in mineral metabolisms.
  4. Patient secondary, Tertiary hyperparathyroidism.

Exclusion Criteria:

  1. patient <18 years old
  2. patient with primary hyperparathyroidism

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
Measure Description
Time Frame
association of markers of mineral metabolism with vascular access out come[maturation and patency of vascular access[AVF,AVG]] .To verify the relationship between vascular access complication (AVF,AVG)
Time Frame: baseline
Aim of the study is to determine the association of markers of mineral metabolism with vascular access out come[maturation, and patency] .To verify the relationship between vascular access complication (AVF,AVG) and lower levels of 25(OH)D, higher levels of fibroblast growth factor 23 (FGF23) and serum calcium, phosphorus, parathyroid hormone (PTH) in patients with ESRD on regular hemodialysis.
baseline

Collaborators and Investigators

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

Sponsor

Soad Elsayed Abu douh

Investigators

  • Principal Investigator: Eman mohammed, 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 (Anticipated)

September 1, 2023

Primary Completion (Anticipated)

September 1, 2024

Study Completion (Anticipated)

November 1, 2024

Study Registration Dates

First Submitted

April 8, 2023

First Submitted That Met QC Criteria

May 2, 2023

First Posted (Estimate)

May 11, 2023

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 2, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • mineral metabolism in ESRD

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.

Clinical Trials on Disorders of Calcium and Bone Metabolism

Clinical Trials on vascular acess

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Zambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe