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

May 13, 2017 updated by: walaa soliman, Assiut University
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The Patients will be subjected to the following:

1.A full history and thorough clinical evaluation. 2. Estimated GFR of patients will calculated using CKD-epidemiology collaboration formula, Modified Medried formula: (Coresh J .,2007). 3.Biochemistry and hemograms will be done for all patients and controls: i. peripheral blood count :

  • The neutrophil to lymphocyte ratio (NLR) will be calculated. NLR values are normal ,if the value is between 0.78 and 3.58.( Forget P et al 2017).
  • Mean platelet volume (MPV) : 7.2-11.7 fL (Hilmi Demiri et al 2011) Then, the relationship between MPV/NLR will be evaluated ii. urine analysis . iii. renal function tests iv. 24 hour urine protein if proteinuria is detected v. 24 hour urine microalbumin vi. liver function tests vii. lipid profile after fasting 12 hours viii. serum uric acid ix. CRP x.serum fibrinogen level

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Studying the Relationship Between Mean Platelet Volume and Neutrophil/ Lymphocyte Ratio With Inflammation and Proteinuria in Chronic Kidney Disease
Time Frame: 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.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Assuit University 96

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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