Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 2:00 AM
Study NCT ID:
NCT05472805
Status:
COMPLETED
Last Update Posted:
2022-07-25
First Post:
2022-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Predict Carotid Intima-Media Thickness in Chronic Kidney Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2022-07-21', 'studyFirstSubmitQcDate': '2022-07-21', 'lastUpdatePostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neutrophil-lymphocyte ratio (NLR)', 'timeFrame': 'Only in admission', 'description': 'The absolute values of neutrophils that divided by the absolute values of lymphocytes'}, {'measure': 'Platelet-lymphocyte ratio (PLR)', 'timeFrame': 'Only in admission', 'description': 'The absolute values of platelet that divided by the absolute values of lymphocytes'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neutrophil-lymphocyte ratio', 'platelet-lymphocyte ratio', 'carotid intima-media thickness', 'chronic kidney disease', 'dialysis'], 'conditions': ['Chronic Kidney Diseases', 'Dialysis; Complications', 'Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nPatients 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.\n\nThe 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of CKD stage V\n* on HD or CAPD based RRTs\n\nExclusion Criteria:\n\n* cardiovascular, neoplastic, chronic inflammatory, or infectious disease\n* usage of immunosuppressants or antiplatelet drugs'}, 'identificationModule': {'nctId': 'NCT05472805', 'briefTitle': 'Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Predict Carotid Intima-Media Thickness in Chronic Kidney Disease Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sebelas Maret'}, 'officialTitle': 'The Relationship of Neutrophil-Lymphocyte Ratio and Platelet-Lymphocyte Ratio to Carotid Intima-Media Thickness in Chronic Kidney Disease Patients Undergoing Dialysis', 'orgStudyIdInfo': {'id': 'NLRandPLRtoCIMTinCKD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CIMT ≥1mm', 'description': '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'}, {'label': 'CIMT <1mm', 'description': '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'}]}, 'contactsLocationsModule': {'locations': [{'zip': '57145', 'city': 'Surakarta', 'state': 'Central Java', 'country': 'Indonesia', 'facility': 'RS UNS (Universitas Sebelas Maret Hospital)', 'geoPoint': {'lat': -7.55611, 'lon': 110.83167}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sebelas Maret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Nurhasan Agung Prabowo', 'investigatorAffiliation': 'Universitas Sebelas Maret'}}}}