Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.

Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.

Cardiovascular disease (CVD) is the major risk factor for death in end stage renal diseases (ESRD). Approximately 80% of ESRD patients have some degrees of left ventricular abnormalities at initiation of dialysis. Carotid intima media thickness (CIMT) has been widely accepted as an useful marker to assess CVD in ESRD children. In addition, cardiac mechanics parameters are used to evaluate cardiac function more precisely. However, measuring CIMT and cardiac mechanics parameters are expensive and difficult to perform as a routine method. Mean platelet volume (MPV) is a hematological index which shows the size of platelets. Uremic state causes inflammatory condition that affects MPV. Previous studies on people with normal renal function have shown that this parameter can also have association with CVD. However the data in children with ESRD is scarce. The aim of this study is to find a simple hematologic marker to use regularly in ESRD children finding patients at risk of CVD. Therefore, we will investigate the relationship between mean platelet volume and CIMT and cardiac mechanic parameters in children with ESRD.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; End Stage Renal Disease; Hemodialysis Complication; Children; Left Ventricular Hypertrophy; Peritoneal Dialysis Complication; Mean Platelet Volume; Carotid Intimal Media Thickness
• Intervention / Treatment: Diagnostic test: Imaging; Other: Blood sampling

• Study Type: Observational
• Enrollment (Actual): 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients group will be selected from children who referred to a tertiary care center of pediatric nephrology diseases.

Controls will be chosen from healthy volunteers who will be visited for medical routine examination in the hospital staff.

Description

Inclusion Criteria:

• Children under 18 years who have being dialyzed (hemodialysis or peritoneal dialysis) regularly more than 6 months, as case group.
• Age and gender matched healthy children who have been referred for routine medical examination.

Exclusion Criteria:

• Patients with uncontrolled hypertension (until being stabled)
• Patients on any kind of antithrombotic agents or NSAIDs
• Severe obesity
• Diabetes patients
• Patients with a past history of CVD or stroke in the last 6 months
• Passive smokers who contacted daily with high smokers in their houses
• Patients with known hematologic diseases or malignancies (such as Fanconi Anemia)
• Uncontrolled hypothyroid or hyperthyroid patients
• Patients with recent (in the last 4 weeks) catheter or exit -site infection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Children with end stage renal disease	Diagnostic test: Imaging; Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness; Other: Blood sampling; Blood sampling will performed on all participants for measuring hematological parameters including MPV.
Controls; Healthy sex- and age adjusted children	Diagnostic test: Imaging; Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness; Other: Blood sampling; Blood sampling will performed on all participants for measuring hematological parameters including MPV.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPV in patients and controls	Comparing the mean of MPV in patients and controls.	1 year after study beginning
Echocardiographic indices in patients and controls	Comparing the means of echocardiographic indices in patients and controls	1.5 years after study beginning
Carotid intima media thickness in patients and controls	Comparing the mean of carotid intima media thickness in patients and controls	2 years after study beginning
Correlation between MPV and ejection fraction	Determining correlation between the value of MPV with ejection fraction in patients	1.5 years after study beginning
Correlation between MPV and left ventricular mass index	Determining correlation between the value of MPV with left ventricular mass index in patients	1.5 years after study beginning
Correlation between MPV and strain rate	Determining correlation between the value of MPV with strain rate in patients	1.5 years after study beginning
Correlation between MPV and global longitudinal strain	Determining correlation between the value of MPV with global longitudinal strain in patients	1.5 years after study beginning
Correlation between MPV and carotid intima media thickness	Determining correlation between the value of MPV with carotid intima media thickness in patients	2 years after study beginning

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MPV and thrombotic events	Comparing the values of MPV in patients with and without previous histories of thrombotic events including arteriovenous fistula thrombosis, cerebrovascular accident, deep venous thrombosis, and cerebrovascular accident	2 years after study beginning

Collaborators and Investigators

• Sponsor: Isfahan University of Medical Sciences
• Investigators: Principal Investigator: Alaleh Gheissari, M.D., Professor of pediatric nephrology

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2016
• Primary Completion (ACTUAL): February 1, 2018
• Study Completion (ACTUAL): June 15, 2018

Study Registration Dates

• First Submitted: November 22, 2018
• First Submitted That Met QC Criteria: November 28, 2018
• First Posted (ACTUAL): November 29, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 28, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Urologic Diseases; Renal Insufficiency; Pathological Conditions, Anatomical; Renal Insufficiency, Chronic; Cardiomegaly; Cardiovascular Diseases; Kidney Diseases; Kidney Failure, Chronic; Hypertrophy; Hypertrophy, Left Ventricular
• Other Study ID Numbers: 395723

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No