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

Completed

• Conditions: Cardiovascular Diseases; Mean Platelet Volume; Children; Peritoneal Dialysis Complication; Carotid Intimal Media Thickness; Left Ventricular Hypertrophy; End Stage Renal Disease; Hemodialysis Complication
• Interventions: Diagnostic Test: Imaging; Other: Blood sampling

• Registration Number: NCT03759002
• Lead Sponsor: Isfahan University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-01
• Primary Completion: 2018-02-01
• Study Completion: 2018-06-15
• Status Verified: 2018-11
• Study First Submitted: 2018-11-22
• Study First Submitted QC: 2018-11-28
• Last Update Submitted: 2018-11-28
• Study First Posted: 2018-11-29
• Last Update Posted: 2018-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	Blood sampling	Children with end stage renal disease
Patients	Imaging	Children with end stage renal disease
Controls	Imaging	Healthy sex- and age adjusted children
Controls	Blood sampling	Healthy sex- and age adjusted children

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
MPV and thrombotic events	2 years after study beginning	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