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

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05322447
• Other study ID #: R / 2022
• Status: Completed
• Phase: Phase 4
• Start date: April 15, 2022
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 1, 2022
• Est. primary completion date: August 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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)
• 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

Locations

Country	Name	City	State
Egypt	Faculty of medicine	Cairo
Egypt	Mona A Ammar	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound diaphragmatic function	Diaphragmatic excursion by ultrasound	at days 7