Studying the Relationship Between Mean Platelet Volume and Neutrophil/ Lymphocyte Ratio With Inflammation and Proteinuria in Chronic Kidney Disease

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT03149068
Collaborator
(none)
100
10

Study Details

Study Description

Brief Summary

Inflammation begins during early stages of CKD in which neutrophil counts are increased, whereas lymphocyte counts are decreased during inflammation. In addition to known conventional indications of inflammation such as C-reactive protein (CRP), fibrinogen, erythrocyte sedimentation rate, several interleukins and tumor necrotizing factor alpha, Neutrophil-to-lymphocyte ratio (NLR) has increasingly been reported as a measure of systemic inflammation (Okyay G U et al 2013 and Yilmaz G et al ,2017) Several recent studies have shown that mean platelet volume (MPV) is also increased during inflammation and may be associated with poorer prognosis in CKD (Yilmaz G et al ,2017).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Chronic kidney disease (CKD) is a worldwide problem and its incidence is steadily increasing. Kidney Disease Outcomes Quality Initiative (K/DOQI) of the National Kidney Foundation (NKF) defines chronic kidney disease as either kidney damage or a decreased kidney glomerular filtration rate (GFR) of less than 60 mL/min/1.73 m2 for 3 or more months (Levey AS.,2011). Whatever the underlying etiology, the destruction of renal mass with irreversible sclerosis and loss of nephrons leads to a progressive decline in GFR. CKD progression is associated with high morbidity and mortality (Sanz AB.,2014) .The early detection of CKD is important and early treatment may reduce adverse outcomes associated with CKD and slow or even prevent the progression of the disease. Therefore, the detection of CKD at early stages is an important public health issue (Katherine T.,2015).

    Cardiovascular disease is a leading cause of death in patients with chronic kidney disease (CKD), for whom the cardiovascular mortality rate is 15 to 30 times higher than in the general population. The underlying pathological state is caused by a complex interplay of traditional and nontraditional risk factors that results in atherosclerosis, arteriosclerosis, and altered cardiac morphological characteristics. (Effat et al 2012) Several factors are associated with the onset and progression of CKD, such as obesity, hypertension and diabetes mellitus. Beyond these factors, there is evidence of a pathophysiological role for inflammation in CKD. Inflammation actively participates in the mechanisms of renal damage progression in diseases of several etiologies (Akchurin OM and Kaskel F, 2015). In glomerular diseases, for example, the following sequence is believed to occur: 1) persistent glomerular injury produces capillary hypertension, with increased glomerular filtration and passage of proteins into the tubular fluid; 2) glomerular proteinuria increases the production of angiotensin II and promotes liberation of inflammatory mediators (cytokines and chemokines), which induce the renal interstitial build-up of mononuclear cells; 3) the initial neutrophil recruiting is replaced by macrophages and T lymphocytes, which unleash the immune response producing interstitial nephritis; 4) tubular cells respond to this inflammatory process with injury to their basement membrane and with the epithelial-mesenchymal transition, becoming interstitial fibroblasts; 5) The formed fibroblasts produce collagen which, in turn, injuries the renal vessels and tubules, eventually generating a cellular scar (Vianna H R et al 2011).

    Inflammation begins during early stages of CKD in which neutrophil counts are increased, whereas lymphocyte counts are decreased during inflammation. In addition to known conventional indications of inflammation such as C-reactive protein (CRP), fibrinogen, erythrocyte sedimentation rate, several interleukins and tumor necrotizing factor alpha, Neutrophil-to-lymphocyte ratio (NLR) has increasingly been reported as a measure of systemic inflammation (Okyay G U et al 2013 and Yilmaz G et al ,2017) . It is a simple parameter to assess easily the inflammatory status of a subject and has proven its usefulness in the stratification of mortality in major cardiac events, as a strong prognostic factor in several types of cancers , or as a predictor and a marker of inflammatory or infectious pathologies (ex., pediatric appendicitis) and postoperative complications (Forget P et al 2017). Recent studies have emphasized that NLR could be used as an indication for inflammation and may be associated with poorer prognosis in CKD (Yilmaz G et al ,2017) .

    Several recent studies have shown that mean platelet volume (MPV) is also increased during inflammation and may be associated with poorer prognosis in CKD (Yilmaz G et al ,2017). Platelet activation in patients with chronic kidney disease (CKD) may contribute to cardiovascular mortality. The relationship between mean platelet volume (MPV) and coronary artery disease, atherosclerotic vascular pathologies, and platelet aggregation in CKD is not well established (Altun E et al 2016).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Studying the Relationship Between Mean Platelet Volume and Neutrophil/ Lymphocyte Ratio With Inflammation and Proteinuria in Chronic Kidney Disease
    Anticipated Study Start Date :
    Jul 1, 2017
    Anticipated Primary Completion Date :
    May 1, 2018
    Anticipated Study Completion Date :
    May 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    75 patient

    Seventy five (75) CKD patients in different stages will be included in our study from Nephrology unit, Internal Medicine department, Assuit University Hospital

    25 healthy control

    twenty five (25) age and sex matched apparently healthy individuals will be enrolled as controls

    Outcome Measures

    Primary Outcome Measures

    1. Studying the Relationship Between Mean Platelet Volume and Neutrophil/ Lymphocyte Ratio With Inflammation and Proteinuria in Chronic Kidney Disease [one year]

      The relationship between (MPV) and (NLR) with inflammation and proteinuria in patients with CKD at stage 2 , 3 and 4 by simple parameters.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Patients are eligible for participation in the study if :
    1. Patients between the ages of 19-65 years

    2. CKD patient in stages 2,3,4

    3. GFR values of 15-89 mL/min/1.73 m2

    4. Body mass index ( BMI ) <35 kg/ m2

    Exclusion Criteria:
    • Patients were excluded from the study if :
    1. Diabetes Mellitus patients,

    2. Patients with any active infection,

    3. Patients with any malignancy,

    4. Patients with coronary artery disease ,

    5. Patients on steroids and , or immunosuppressive drugs

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    walaa soliman, assuit, Assiut University
    ClinicalTrials.gov Identifier:
    NCT03149068
    Other Study ID Numbers:
    • Assuit University 96
    First Posted:
    May 11, 2017
    Last Update Posted:
    May 16, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 16, 2017