Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05472805 |
| Other study ID # |
NLRandPLRtoCIMTinCKD |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2022 |
| Est. completion date |
July 1, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Universitas Sebelas Maret |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
