NCT05905692

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

Status unknown Phase 3 Last updated 15 June 2023

What this trial tests

Phase 3 trial testing L Carnitine in Intradialytic Hypotension in 50 participants. Status unknown.

Timeline

30 May 2023

Primary endpoint
10 December 2023

30 December 2023

Quick facts

Lead sponsor	Ain Shams University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	50
Start date	30 May 2023
Primary completion	10 December 2023
Estimated completion	30 December 2023
Sites	1 location across Egypt

Drugs / interventions tested

• L Carnitine

Conditions studied

• Intradialytic Hypotension — all drugs for Intradialytic Hypotension →

Sponsor

Ain Shams University

Who can join

Adults 6 to 18, any sex, with Intradialytic Hypotension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.