Clinical trial NCT03759002: Association of Mean Platelet Volume and Cardiovascular Disease in Children With End Stage Renal Disease.
Official title: Association Between Mean Platelet Volume With Echocardiographic Indices and Carotid Intima Media Thickness in Children With End Stage Renal Disease.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Carotid Intimal Media Thickness
Left Ventricular Hypertrophy
Mean Platelet Volume
End Stage Renal Disease
Hemodialysis Complication
Peritoneal Dialysis Complication
Children
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 102
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.


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.

Primary outcomes:
measure: MPV in patients and controls
timeFrame: 1 year after study beginning
measure: Echocardiographic indices in patients and controls
timeFrame: 1.5 years after study beginning
measure: Carotid intima media thickness in patients and controls
timeFrame: 2 years after study beginning
measure: Correlation between MPV and ejection fraction
timeFrame: 1.5 years after study beginning
measure: Correlation between MPV and left ventricular mass index
timeFrame: 1.5 years after study beginning
measure: Correlation between MPV and strain rate
timeFrame: 1.5 years after study beginning
measure: Correlation between MPV and global longitudinal strain
timeFrame: 1.5 years after study beginning
measure: Correlation between MPV and carotid intima media thickness
timeFrame: 2 years after study beginning
Secondary outcomes:
measure: MPV and thrombotic events
timeFrame: 2 years after study beginning
Other outcomes:
Locations:
Study officials:
affiliation: Professor of pediatric nephrology
name: Alaleh Gheissari, M.D.
role: PRINCIPAL_INVESTIGATOR
References: