Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis

Study Overview
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Brief Summary
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Intradialytic hypotension (IDH) is defined as less than the 5th percentile of SBP measurements and is associated with clinical symptoms, such as abdominal pain, nausea, vomiting, muscle cramps, restlessness, light-headedness, syncope, and anxiety. In adults There is no consensus definition of IDH, however, according to the Kidney Disease Outcomes Quality Initiative and European Best Practice Guidelines, IDH is defined as a decline in systolic blood pressure ≥20 mmHg or a decrease in a mean arterial pressure by 10 mmHg and associated with clinical events like abdominal pain, nausea, vomiting, muscle cramps, dizziness, fatigue, and restlessness. IDH occurs in response to the reduction in blood volume (BV) during ultrafiltration (UF) and subsequent poor compensatory mechanisms due to abnormal cardiac function (left ventricular dysfunction, chamber remodeling, congenital heart diseases, and arrhythmias) or autonomic or baroreceptor failure. To maintain volume status, the body shifts fluid from the interstitial space to the intravascular space and increases heart rate, contractility, and vascular tone. Plasma refilling, another essential factor in maintaining euvolemia, depends on oncotic, osmotic, and hydraulic gradients across vascular beds. If UF rates surpass plasma refilling rates, intravascular volume falls and hypotension results. Hematocrit levels, tissue hydration and arterial vasoconstriction all promote plasma refilling rates. Alterations in these factors during dialysis decrease the plasma refilling rate, resulting in hypotension. Aim of The Work: The aim of this study is to assess and evaluate the efficacy and safety of L Carnitine in the prevention of intradialytic hypotension in pediatric patients on regular hemodialysis.

Official Title
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Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis

Conditions
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Intradialytic Hypotension

Intervention / Treatment
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* Drug: L Carnitine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 6-18 years Patients on hemodialysis for 3 months or longer Patients on hemodialysis frequency 3 times weekly (with the same dialysate concentration and temperature) Patients who had two or more episodes of intradialytic hypotension during dialysis (less than the 5th percentile of SBP measurements and is associated with clinical symptoms) in the last 3 months. Exclusion Criteria: Patients with life expectancy < 3 months Patients with known hypersensitivity to L carnitine Patients received L carnitine in the previous 6 months

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L carnitine group<br>patients will take L carnitine (20 mg/kg/day) 3 times per week (on the same days of the dialysis session, 30 minutes before the session) | Drug: L Carnitine<br>* L carnitine will be given to group 1 (20 mg/kg/day) 3 times per week<br>|
| Placebo Comparator: Placebo group<br>patients will take placebo 3 times per week (on the same days of the dialysis session, 30 minutes before the session) | Drug: L Carnitine<br>* L carnitine will be given to group 1 (20 mg/kg/day) 3 times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of events of intradialytic hypotension | how many times intradialytic hypotension occurs | Baseline | 
| The number of events of intradialytic hypotension | how many times intradialytic hypotension occurs | 3 months (end of the study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of any adverse effects or side effect in the L carnitine group. | monitor the adverse effect that can occur in group 2 due to the drug | up to 3 months |