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
About this trial
This is an interventional treatment trial for Respiratory Failure
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.
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
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
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High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.
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