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

NCT ID: NCT05905692

Last Updated: 2023-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-30
• Study Completion Date: 2023-12-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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)

Group Type: EXPERIMENTAL

L Carnitine

Intervention Type: DRUG

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

Placebo group

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

Group Type: PLACEBO_COMPARATOR

L Carnitine

Intervention Type: DRUG

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

Interventions

L Carnitine

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Radwa Maher Abd El Kader El Borolossy

Lecturer of clinical pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Radwa Maher El Borolossy

Cairo, , Egypt

Countries

Egypt

Other Identifiers

RHDIRB202011031 REC#154

Identifier Type: -

Identifier Source: org_study_id