High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.
Effect of High-dose L-Carnitine Supplementation on Diaphragmatic Function Assessed by Ultrasonography in Critically Ill Patients With Respiratory Failure: a Randomized Clinical Trial
1 other identifier
interventional
60
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2022
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
April 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedOctober 17, 2022
October 1, 2022
4 months
March 21, 2022
October 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Ultrasound diaphragmatic function
Diaphragmatic excursion by ultrasound
at days 7
Study Arms (2)
Control Group
OTHERmaintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)
experimental group
EXPERIMENTALhigh dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level.
Interventions
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)
will receive a high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Faculty of medicine
Cairo, 1234, Egypt
Mona A Ammar
Cairo, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 21, 2022
First Posted
April 11, 2022
Study Start
April 15, 2022
Primary Completion
August 4, 2022
Study Completion
October 1, 2022
Last Updated
October 17, 2022
Record last verified: 2022-10