Cardiovascular ComplicationNCT05754827
RDW to Platlet Count Ratio in CKD Patients
An observational study of Cardiovascular Complication, run by Sohag University.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Complication
- What is being tested?
- RDW to platlet count ratio
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 22 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: CKD Patients and patients receive dialysis admitted to Sohag University hospital at period of admission 18 years or older.
Who may be able to join
- CKD Patients and patients receive dialysis >18 years old
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Ali M Kassem contact
About this study
Official title: Red Blood Cell Distribution Width to Platelet Count Ratio as a Predictor of Cardiovascular Complications in CKD Patients
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
Read the detailed description
comparative study between RDW to Platlet count ratio in CKD patients without cardiovascular complications and CKD patients with cardiovascular complications
- Conditions
- Cardiovascular Complication
- Being tested
- RDW to platlet count ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDW to platlet count ratioDiagnostic test
RDW to platlet ratio will be measured for all patients and results will be compared between groups
| Study group | Role | What they receive |
|---|---|---|
| 1-CKD patients without cardiovascular complications | Not described Receives: Diagnostic Test: RDW to platlet count ratio | |
| 2-CKD patients with cardiovascular complications | Not described Receives: Diagnostic Test: RDW to platlet count ratio |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion22 Feb 2024 (estimated)
- Study completion22 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular ComplicationStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doha Aly Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754827
- Sponsor's protocol ID
- CKD and CV complications
- Status last verified
- Mar 2023
- First submitted
- 22 Feb 2023
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33720773
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Distribution Width to Platelet Count Ratio as a Predictor of Cardiovascular Complications in CKD Patients
- ClinicalTrials.gov ID
- NCT05754827
- Acronym / sponsor ID
- CKD and CV complications
- Conditions
- Cardiovascular Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 22 Feb 2024 (estimated)
- Study completion
- 22 Mar 2024 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
comparative study between RDW to Platlet count ratio in CKD patients without cardiovascular complications and CKD patients with cardiovascular complications
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- CKD Patients and patients receive dialysis admitted to Sohag University hospital at period of admission 18 years or older.
Key inclusion criteria (1 listed)
Key exclusion criteria (7 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDW to platlet count ratioRDW to platlet ratio will be measured for all patients and results will be compared between groups | Diagnostic test | 1-CKD patients without cardiovascular complications, 2-CKD patients with cardiovascular complications |
Primary outcome
Comparison of results of RDW to platlet ratio in CKD patients
Time frame: 1 year
Calculate RDW to platlet ratio for CKD patints with or without cardiovascular complications and compare the results
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2023.
- Background: PubMed 33720773Jankowski 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali M Kassem contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Complication, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doha A Mohamed (01016547932, dohaaly@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of results of RDW to platlet ratio in CKD patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05754827, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2023.