NCT05754827

Brief Summary

The aim of the study is to determine Red blood cell distribution width to platelet count ratio as a predictor of cardiovascular complications in CKD patients

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2024

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2024

Completed
Last Updated

March 16, 2023

Status Verified

March 1, 2023

Enrollment Period

11 months

First QC Date

February 22, 2023

Last Update Submit

March 14, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of results of RDW to platlet ratio in CKD patients

    Calculate RDW to platlet ratio for CKD patints with or without cardiovascular complications and compare the results

    1 year

Study Arms (2)

1-CKD patients without cardiovascular complications

Diagnostic Test: RDW to platlet count ratio

2-CKD patients with cardiovascular complications

Diagnostic Test: RDW to platlet count ratio

Interventions

RDW to platlet ratio will be measured for all patients and results will be compared between groups

1-CKD patients without cardiovascular complications2-CKD patients with cardiovascular complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

CKD Patients and patients receive dialysis admitted to Sohag University hospital at period of admission 18 years or older.

You may qualify if:

  • CKD Patients and patients receive dialysis \>18 years old

You may not qualify if:

  • Serious complications of any other organs
  • patients who had previously undergone kidney transplantation .
  • CKD patients with history of previous CVD
  • patients with an infection, blood transfusion or receiving immunosuppressive drugs, as this may have affected the inflammatory response within the 3 months
  • patients who were pregnant
  • patients with chronic hematological disease
  • patient\<18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jankowski J, Floege J, Fliser D, Bohm M, Marx N. Cardiovascular Disease in Chronic Kidney Disease: Pathophysiological Insights and Therapeutic Options. Circulation. 2021 Mar 16;143(11):1157-1172. doi: 10.1161/CIRCULATIONAHA.120.050686. Epub 2021 Mar 15.

    PMID: 33720773BACKGROUND

Central Study Contacts

Ali M Kassem

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 22, 2023

First Posted

March 6, 2023

Study Start

April 1, 2023

Primary Completion

February 22, 2024

Study Completion

March 22, 2024

Last Updated

March 16, 2023

Record last verified: 2023-03