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

Sponsor
Ain Shams University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05322447
Collaborator
(none)
60
Enrollment
2
Locations
2
Arms
2.3
Anticipated Duration (Months)
30
Patients Per Site
13.2
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: L Carnitine ( low dose)
  • Drug: L-Carnitine ( high dose)
 Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
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
Actual Study Start Date :
May 24, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Ultrasound diaphragmatic function [at days 7]

    Diaphragmatic excursion by ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine Cairo Egypt 1234
2 Mona A Ammar Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mona Ammar, Assistant Professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT05322447
Other Study ID Numbers:
  • R / 2022
First Posted:
Apr 11, 2022
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Respiratory Insufficiency

Study Results

No Results Posted as of Jun 8, 2022