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

Phase 4

Completed

• Conditions: Respiratory Failure
• Interventions: Drug: L Carnitine ( low dose); Drug: L-Carnitine ( high dose)

• Registration Number: NCT05322447
• Lead Sponsor: Ain Shams University

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-21
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Study Start: 2022-04-15
• Primary Completion: 2022-08-04
• Status Verified: 2022-10
• Study Completion: 2022-10-01
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	L Carnitine ( low dose)	maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)
experimental group	L-Carnitine ( high dose)	high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level.

Primary Outcome Measures

Name	Time	Method
Ultrasound diaphragmatic function	at days 7	Diaphragmatic excursion by ultrasound

Trial Locations

Locations (2)

Faculty of medicine; 🇪🇬 Cairo, Egypt

Mona A Ammar; 🇪🇬 Cairo, Egypt