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

NCT03759002 | Completed

• 1 other identifier: 395723
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• MPV and thrombotic events

  2 years after study beginning

Study Arms (2)

Patients

Children with end stage renal disease

Diagnostic Test: Imaging; Other: Blood sampling

Controls

Healthy sex- and age adjusted children

Diagnostic Test: Imaging; Other: Blood sampling

Interventions

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

Controls; Patients

Blood sampling OTHER

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

Controls; Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertrophy, Left Ventricular; Kidney Failure, Chronic

Interventions

Diagnostic Imaging; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Cardiomegaly; Heart Diseases; Hypertrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Alaleh Gheissari, M.D.

  Professor of pediatric nephrology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical researcher

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: November 29, 2018
• Study Start: February 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: June 15, 2018
• Last Updated: November 29, 2018

Record last verified: 2018-11