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High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
L Carnitine ( low dose)
L-Carnitine ( high dose)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age from 21 years old or greater
  • Both genders have respiratory failure either of the primary medical origin or in the post-surgical course.
  • Not in need of mechanical ventilation

Exclusion Criteria:

  • Renal failure on regular dialysis
  • Hypothyroidism
  • Seizures
  • End-stage liver disease
  • Mechanical ventilation
  • History or discovered allergy to L-carnitine, pivampicillin, and other pivalate-conjugated antibiotics.

Sites / Locations

  • Faculty of medicine
  • Mona A Ammar

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control Group

experimental group

Arm Description

maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)

high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level.

Outcomes

Primary Outcome Measures

Ultrasound diaphragmatic function
Diaphragmatic excursion by ultrasound

Secondary Outcome Measures

Full Information

First Posted
March 21, 2022
Last Updated
October 14, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05322447
Brief Title
High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.
Official Title
Effect of High-dose L-Carnitine Supplementation on Diaphragmatic Function Assessed by Ultrasonography in Critically Ill Patients With Respiratory Failure: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 15, 2022 (Actual)
Primary Completion Date
August 4, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

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

5. Study Description

Brief Summary
L-Carnitine supplementation has been shown to boost muscular performance in several studies. In hemodialysis patients with muscular weakness, fatigue, or cramps/aches, after L-carnitine treatment, about two-thirds of patients had at least some improvement in muscular symptoms . L-Carnitine was also found to improve the left ventricular ejection fraction (LVEF) in hemodialysis patients with cardiac morbidity who had significantly reduced LVEF in echocardiography before supplementation. Moreover, L-Carnitine has been shown to improve muscular function and exercise performance in athletes in several studies

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Other
Arm Description
maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)
Arm Title
experimental group
Arm Type
Experimental
Arm Description
high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level.
Intervention Type
Drug
Intervention Name(s)
L Carnitine ( low dose)
Intervention Description
will receive a maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)
Intervention Type
Drug
Intervention Name(s)
L-Carnitine ( high dose)
Intervention Description
will receive a high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level
Primary Outcome Measure Information:
Title
Ultrasound diaphragmatic function
Description
Diaphragmatic excursion by ultrasound
Time Frame
at days 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age from 21 years old or greater Both genders have respiratory failure either of the primary medical origin or in the post-surgical course. Not in need of mechanical ventilation Exclusion Criteria: Renal failure on regular dialysis Hypothyroidism Seizures End-stage liver disease Mechanical ventilation History or discovered allergy to L-carnitine, pivampicillin, and other pivalate-conjugated antibiotics.
Facility Information:
Facility Name
Faculty of medicine
City
Cairo
ZIP/Postal Code
1234
Country
Egypt
Facility Name
Mona A Ammar
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.

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