Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03149068 |
| Other study ID # |
Assuit University 96 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
May 2, 2017 |
| Last updated |
May 13, 2017 |
| Start date |
July 1, 2017 |
| Est. completion date |
May 1, 2018 |
Study information
| Verified date |
May 2017 |
| Source |
Assiut University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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).
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).
