Skip to main content
OpenTrials
Completed

NCT Number: NCT03759002

Association of Mean Platelet Volume and Cardiovascular Disease 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiovascular Diseases Cardiomegaly Carotid Intimal Media Thickness Children Chronic Disease Disease Attributes End Stage Renal Disease Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Hemodialysis Complication Hypertrophy Hypertrophy, Left Ventricular Kidney Diseases Kidney Failure, Chronic Left Ventricular Hypertrophy Male Urogenital Diseases Mean Platelet Volume Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Peritoneal Dialysis Complication Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Imaging

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

Other

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

Primary outcomes

  1. MPV in patients and controls

    Time frame: 1 year after study beginning

    Comparing the mean of MPV in patients and controls.

  2. Echocardiographic indices in patients and controls

    Time frame: 1.5 years after study beginning

    Comparing the means of echocardiographic indices in patients and controls

  3. Carotid intima media thickness in patients and controls

    Time frame: 2 years after study beginning

    Comparing the mean of carotid intima media thickness in patients and controls

  4. Correlation between MPV and ejection fraction

    Time frame: 1.5 years after study beginning

    Determining correlation between the value of MPV with ejection fraction in patients

  5. Correlation between MPV and left ventricular mass index

    Time frame: 1.5 years after study beginning

    Determining correlation between the value of MPV with left ventricular mass index in patients

  6. Correlation between MPV and strain rate

    Time frame: 1.5 years after study beginning

    Determining correlation between the value of MPV with strain rate in patients

  7. Correlation between MPV and global longitudinal strain

    Time frame: 1.5 years after study beginning

    Determining correlation between the value of MPV with global longitudinal strain in patients

  8. Correlation between MPV and carotid intima media thickness

    Time frame: 2 years after study beginning

    Determining correlation between the value of MPV with carotid intima media thickness in patients

Secondary outcomes

  1. MPV and thrombotic events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 29, 2018
Registry last updated
Nov 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.