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

Primary Purpose

Intradialytic Hypotension

Status
Active
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
L Carnitine
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intradialytic Hypotension

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radwa Maher El Borolossy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

L carnitine group

Placebo group

Arm Description

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)

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

Outcomes

Primary Outcome Measures

The number of events of intradialytic hypotension
how many times intradialytic hypotension occurs
The number of events of intradialytic hypotension
how many times intradialytic hypotension occurs

Secondary Outcome Measures

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

Full Information

First Posted
May 29, 2023
Last Updated
June 14, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05905692
Brief Title
Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis
Official Title
Evaluation of the Impact of L- Carnitine in Intradialytic Hypotension in Pediatric Patients on Regular Hemodialysis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 30, 2023 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intradialytic Hypotension

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
L carnitine group
Arm Type
Experimental
Arm Description
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)
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
patients will take placebo 3 times per week (on the same days of the dialysis session, 30 minutes before the session)
Intervention Type
Drug
Intervention Name(s)
L Carnitine
Intervention Description
L carnitine will be given to group 1 (20 mg/kg/day) 3 times per week
Primary Outcome Measure Information:
Title
The number of events of intradialytic hypotension
Description
how many times intradialytic hypotension occurs
Time Frame
Baseline
Title
The number of events of intradialytic hypotension
Description
how many times intradialytic hypotension occurs
Time Frame
3 months (end of the study)
Secondary Outcome Measure Information:
Title
development of any adverse effects or side effect in the L carnitine group.
Description
monitor the adverse effect that can occur in group 2 due to the drug
Time Frame
up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Radwa Maher El Borolossy
City
Cairo
ZIP/Postal Code
0000
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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