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

NCT ID: NCT03759002

Last Updated: 2018-11-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 102 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-01
• Study Completion Date: 2018-06-15

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.

Conditions

Cardiovascular Diseases; Carotid Intimal Media Thickness; Left Ventricular Hypertrophy; Mean Platelet Volume; End Stage Renal Disease; Hemodialysis Complication; Peritoneal Dialysis Complication; Children

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Patients

Children with end stage renal disease

Imaging

Intervention Type: DIAGNOSTIC_TEST

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

Blood sampling

Intervention Type: OTHER

Blood sampling will performed on all participants for measuring hematological parameters including MPV.

Controls

Healthy sex- and age adjusted children

Imaging

Intervention Type: DIAGNOSTIC_TEST

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

Blood sampling

Intervention Type: OTHER

Blood sampling will performed on all participants for measuring hematological parameters including MPV.

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Blood sampling

Blood sampling will performed on all participants for measuring hematological parameters including MPV.

Intervention Type: OTHER

Eligibility Criteria

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.

• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Amin Abedini

Medical researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alaleh Gheissari, M.D.

Role: PRINCIPAL_INVESTIGATOR

Professor of pediatric nephrology

Other Identifiers

395723

Identifier Type: -

Identifier Source: org_study_id