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

NCT05905692 | Unknown Phase 3

• 1 other identifier: RHDIRB202011031 REC#154
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intradialytic Hypotension

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• development of any adverse effects or side effect in the L carnitine group.

  up to 3 months

Study Arms (2)

L carnitine group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

patients will take placebo 3 times per week (on the same days of the dialysis session, 30 minutes before the session)

Drug: L Carnitine

Interventions

L Carnitine DRUG

L carnitine will be given to group 1 (20 mg/kg/day) 3 times per week

L carnitine group; Placebo group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with life expectancy \< 3 months
• Patients with known hypersensitivity to L carnitine
• Patients received L carnitine in the previous 6 months

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Radwa Maher El Borolossy

Cairo, 0000, Egypt

Location

MeSH Terms

Interventions

Carnitine

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of clinical pharmacy

Study Record Dates

• First Submitted: May 29, 2023
• First Posted: June 15, 2023
• Study Start: May 30, 2023
• Primary Completion: December 10, 2023
• Study Completion: December 30, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)