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

NCT ID: NCT05322447

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-15
• Study Completion Date: 2022-10-01

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

Conditions

Respiratory Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control Group

maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L)

Group Type: OTHER

L Carnitine ( low dose)

Intervention Type: DRUG

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 group

high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level.

Group Type: EXPERIMENTAL

L-Carnitine ( high dose)

Intervention Type: DRUG

will receive a high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level

Interventions

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)

Intervention Type: 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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mona Ammar

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of medicine

Cairo, , Egypt

Mona A Ammar

Cairo, , Egypt

Countries

Egypt

Other Identifiers

R / 2022

Identifier Type: -

Identifier Source: org_study_id