NCT05472805

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 21, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

6 months

First QC Date

July 21, 2022

Last Update Submit

July 21, 2022

Conditions

Keywords

neutrophil-lymphocyte ratioplatelet-lymphocyte ratiocarotid intima-media thicknesschronic kidney diseasedialysis

Outcome Measures

Primary Outcomes (2)

  • Neutrophil-lymphocyte ratio (NLR)

    The absolute values of neutrophils that divided by the absolute values of lymphocytes

    Only in admission

  • Platelet-lymphocyte ratio (PLR)

    The absolute values of platelet that divided by the absolute values of lymphocytes

    Only in admission

Study Arms (2)

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

Eligibility Criteria

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

You may qualify if:

  • diagnosis of CKD stage V
  • on HD or CAPD based RRTs

You may not qualify if:

  • cardiovascular, neoplastic, chronic inflammatory, or infectious disease
  • usage of immunosuppressants or antiplatelet drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RS UNS (Universitas Sebelas Maret Hospital)

Surakarta, Central Java, 57145, Indonesia

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicCoronary Disease

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

July 21, 2022

First Posted

July 25, 2022

Study Start

January 1, 2022

Primary Completion

July 1, 2022

Study Completion

July 1, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations