Chronic Kidney DiseasesNCT05472805
Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Predict Carotid Intima-Media Thickness in Chronic Kidney Disease Patients
An observational study of Chronic Kidney Diseases and Dialysis; Complications, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
This study aims to determine whether the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) can be used as predictors of coronary heart disease (CHD) in CKD patients undergoing dialysis at Moewardi General Hospital Surakarta. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases, Dialysis; Complications, Coronary Heart Disease
- How many people
- 72 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jan 2022to 1 Jul 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a diagnosis of CKD stage V on HD or CAPD based RRTs from the department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022.
Who may be able to join
- diagnosis of CKD stage V
- on HD or CAPD based RRTs
Who cannot join
- cardiovascular, neoplastic, chronic inflammatory, or infectious disease
- usage of immunosuppressants or antiplatelet drugs
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
RS UNS (Universitas Sebelas Maret Hospital)
Surakarta, Central Java, 57145
About this study
Official title: The Relationship of Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Carotid Intima-Media Thickness in Chronic Kidney Disease Patients Undergoing Dialysis
This study aims to determine whether the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) can be used as predictors of coronary heart disease (CHD) in CKD patients undergoing dialysis at Moewardi General Hospital Surakarta. It was hypothesized that NLR and PLR, which have been identified as inflammatory biomarkers, would be significantly related to increased arotid intima-media thickness (CIMT) in CKD patients undergoing dialysis. This study is an observational analytic study using a cross-sectional approach conducted at department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022.
Read the detailed description
This study is an observational analytic study using a cross-sectional approach conducted at department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022. All patients aged 18 years old or older, with a diagnosis of CKD stage V and on HD or CAPD based RRTs were included in the study. The presence of cardiovascular, neoplastic, chronic inflammatory, or infectious disease, and usage of immunosuppressants or antiplatelet drugs precludes the patient from participating in the study.
The main outcome in this study is the presence of a high risk of CHD characterized by CIMT ≥1 mm. The risk of CHD will be operated as categorical variable; CIMT <1 mm and CIMT ≥1 mm. The main predictors used in this study are NLR and PLR. The absolute values of neutrophils and platelets were divided by the absolute values of lymphocytes to get the NLR and PLR values, respectively. Several confounding variables were also considered, including age, gender, nutrition status, CKD duration, presence of diabetes mellitus, and other hematologic parameters. These hematologic parameters include hemoglobin, leukocyte count, platelet count, neutrophils, and lymphocytes. These predictors will be operated as numerical or categorical variables, accordingly.
Patients that met the inclusion and exclusion criteria will be asked to sign an informed consent followed by history-taking and blood sampling. The blood samples were then ordered for a routine hematology examination carried out using a hematology analyzer in the clinical pathology department. The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded.
The data were first exported to Microsoft Excel and then imported into Statistical Package for the Social Sciences (version 22) for quantitative statistical analysis software. All variables were subjected to descriptive statistics in order to describe the subject's frequency, percentage, means, and standard deviations prior to analysis. Homogeneity analysis was also performed in order to identify the factor of the confounding variable in the final analysis. Separate logistic regression models were performed to analyze the relationship between the main predictors and the main outcome. A separate analysis was conducted for each predictor. This study was approved by Health Research Ethics Committee in Moewardi General Hospital with the number: 1.320/XII/HREC/2020.
- Keywords
- neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, carotid intima-media thickness, chronic kidney disease, dialysis
- Medical subject headings
- Renal Insufficiency, Chronic, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CIMT ≥1mm | The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded. This group includes individual with CIMT ≥1mm | |
| CIMT <1mm | The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded. This group includes individual with CIMT <1mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-lymphocyte ratio (NLR)
The absolute values of neutrophils that divided by the absolute values of lymphocytes
Measured: Only in admission
Platelet-lymphocyte ratio (PLR)
The absolute values of platelet that divided by the absolute values of lymphocytes
Measured: Only in admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start1 Jan 2022
- Primary completion1 Jul 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurhasan Agung Prabowo, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472805
- Sponsor's protocol ID
- NLRandPLRtoCIMTinCKD
- Status last verified
- Jul 2022
- First submitted
- 21 Jul 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Carotid Intima-Media Thickness in Chronic Kidney Disease Patients Undergoing Dialysis
- ClinicalTrials.gov ID
- NCT05472805
- Acronym / sponsor ID
- NLRandPLRtoCIMTinCKD
- Keywords
- neutrophil-lymphocyte ratio, platelet-lymphocyte ratio, carotid intima-media thickness, chronic kidney disease, dialysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 25 Jul 2022 (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.
This study aims to determine whether the neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR) can be used as predictors of coronary heart disease (CHD) in CKD patients undergoing dialysis at Moewardi General Hospital Surakarta. It was hypothesized that NLR and PLR, which have been identified as inflammatory biomarkers, would be significantly related to increased arotid intima-media thickness (CIMT) in CKD patients undergoing dialysis. This study is an observational analytic study using a cross-sectional approach conducted at department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022.
Detailed description
This study is an observational analytic study using a cross-sectional approach conducted at department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022. All patients aged 18 years old or older, with a diagnosis of CKD stage V and on HD or CAPD based RRTs were included in the study. The presence of cardiovascular, neoplastic, chronic inflammatory, or infectious disease, and usage of immunosuppressants or antiplatelet drugs precludes the patient from participating in the study.
The main outcome in this study is the presence of a high risk of CHD characterized by CIMT ≥1 mm. The risk of CHD will be operated as categorical variable; CIMT <1 mm and CIMT ≥1 mm. The main predictors used in this study are NLR and PLR. The absolute values of neutrophils and platelets were divided by the absolute values of lymphocytes to get the NLR and PLR values, respectively. Several confounding variables were also considered, including age, gender, nutrition status, CKD duration, presence of diabetes mellitus, and other hematologic parameters. These hematologic parameters include hemoglobin, leukocyte count, platelet count, neutrophils, and lymphocytes. These predictors will be operated as numerical or categorical variables, accordingly.
Patients that met the inclusion and exclusion criteria will be asked to sign an informed consent followed by history-taking and blood sampling. The blood samples were then ordered for a routine hematology examination carried out using a hematology analyzer in the clinical pathology department. The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded.
The data were first exported to Microsoft Excel and then imported into Statistical Package for the Social Sciences (version 22) for quantitative statistical analysis software. All variables were subjected to descriptive statistics in order to describe the subject's frequency, percentage, means, and standard deviations prior to analysis. Homogeneity analysis was also performed in order to identify the factor of the confounding variable in the final analysis. Separate logistic regression models were performed to analyze the relationship between the main predictors and the main outcome. A separate analysis was conducted for each predictor. This study was approved by Health Research Ethics Committee in Moewardi General Hospital with the number: 1.320/XII/HREC/2020.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CIMT ≥1mm | – | –The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded. This group includes individual with CIMT ≥1mm |
| CIMT <1mm | – | –The measurement of CIMT will be carried by a cardiologist in the cardiovascular department using B mode ultrasound. The cardiologist will measure both of the carotid artery, and higher measurement of CIMT will be recorded. This group includes individual with CIMT <1mm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a diagnosis of CKD stage V on HD or CAPD based RRTs from the department of renal-hypertension and hemodialysis unit in Moewardi General Hospital in Surakarta, Indonesia from January to July 2022.
Key inclusion criteria (2 listed)
- diagnosis of CKD stage V
- on HD or CAPD based RRTs
Key exclusion criteria (2 listed)
- cardiovascular, neoplastic, chronic inflammatory, or infectious disease
- usage of immunosuppressants or antiplatelet drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Neutrophil-lymphocyte ratio (NLR)
Time frame: Only in admission
The absolute values of neutrophils that divided by the absolute values of lymphocytes
Platelet-lymphocyte ratio (PLR)
Time frame: Only in admission
The absolute values of platelet that divided by the absolute values of lymphocytes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases and Dialysis; Complications, run by Universitas Sebelas Maret at 1 site in Indonesia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-lymphocyte ratio (NLR) (time frame: Only in admission). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2022; AzTrials last refreshed its copy on 8 Nov 2026.