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

Intradialytic Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05905692
• Other study ID #: RHDIRB202011031 REC#154
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 30, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: June 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 30, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Intradialytic Hypotension

Intervention

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

Locations

Country	Name	City	State
Egypt	Radwa Maher El Borolossy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of events of intradialytic hypotension	how many times intradialytic hypotension occurs	Baseline
Primary	The number of events of intradialytic hypotension	how many times intradialytic hypotension occurs	3 months (end of the study)
Secondary	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