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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Drug: L Carnitine ( low dose); Drug: L-Carnitine ( high dose)

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Mona A Ammar
  • Cairo, Egypt, 1234
    • Faculty of medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control Group; maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)	Drug: L Carnitine ( low dose); 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)
EXPERIMENTAL: experimental group; high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level.	Drug: L-Carnitine ( high dose); will receive a high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound diaphragmatic function	Diaphragmatic excursion by ultrasound	at days 7

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2022
• Primary Completion (ACTUAL): August 4, 2022
• Study Completion (ACTUAL): October 1, 2022

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (ACTUAL): April 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: R / 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No