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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Intradialytic Hypotension
• Intervention / Treatment: Drug: L Carnitine

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 0000
    • Radwa Maher El Borolossy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2023
• Primary Completion (Estimated): December 10, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 29, 2023
• First Submitted That Met QC Criteria: June 14, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: RHDIRB202011031 REC#154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No