Evaluation of the Impact of L- Carnitine in Intradialytic... | NCT05905692

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

NCT05905692

Sponsor

Ain Shams University

Status

Unknown status

Last Update Posted

Jun 15, 2023Actual

Enrollment

50Actual

Phase

Phase 3

Conditions

Intradialytic Hypotension

Interventions

L Carnitine

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 30, 2023Actual

Primary Completion Date

Dec 10, 2023Estimated

Completion Date

Dec 30, 2023Estimated

First Submitted Date

May 29, 2023

First Submission Date that Met QC Criteria

Jun 14, 2023

First Posted Date

Jun 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 14, 2023

Last Update Posted Date

Jun 15, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Radwa Maher Abd El Kader El Borolossy, Lecturer of clinical pharmacy, Ain Shams UniversityPrincipal Investigator

Lead Sponsor

Ain Shams UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
L Carnitine	Drug	L carnitine will be given to group 1 (20 mg/kg/day) 3 times per week	L carnitine group Placebo group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Radwa Maher El Borolossy		Cairo		0000	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002331	Carnitine

Ancestor Terms

ID	Term
D050337	Trimethyl Ammonium Compounds
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals

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Browse Branches

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