Respiratory FailurePhase 4NCT05322447
High-dose L-Carnitine and Diaphragmatic Function Assessed by Ultrasonography in Patients With Respiratory Failure.
A Phase 4 study testing L Carnitine ( low dose) and L-Carnitine ( high dose) in people with Respiratory Failure, run by Ain Shams University at 2 sites in Egypt.
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 . Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- L Carnitine ( low dose) and L-Carnitine ( high dose)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Apr 2022to 1 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
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
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
- Being tested
- L Carnitine ( low dose), L-Carnitine ( high dose)
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L Carnitine ( low dose)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)
L-Carnitine ( high dose)Drug
will receive a high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Other | maintenance dose of L- carnitine 6 gm/day to keep normal level (normal L-carnitine level is normal 25-50 mmol/L) Receives: Drug: L Carnitine ( low dose) |
| experimental group | Experimental | high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level. Receives: Drug: L-Carnitine ( high dose) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound diaphragmatic function
Diaphragmatic excursion by ultrasound
Measured: at days 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start15 Apr 2022
- Primary completion4 Aug 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Ammar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322447
- Sponsor's protocol ID
- R / 2022
- Status last verified
- Oct 2022
- First submitted
- 21 Mar 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05322447
- Acronym / sponsor ID
- R / 2022
- Conditions
- Respiratory Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 4 Aug 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Other | Drug: 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 | Experimental | Drug: L-Carnitine ( high dose)high dose of L- Carnitine 18 gm/day as a continuous intravenous infusion to reach double the normal plasma level. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Renal failure on regular dialysis
- Hypothyroidism
- Seizures
- End-stage liver disease
- Mechanical ventilation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Drug | Control Group |
| 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 | Drug | experimental group |
Primary outcome
Ultrasound diaphragmatic function
Time frame: at days 7
Diaphragmatic excursion by ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing L Carnitine ( low dose) and L-Carnitine ( high dose) in people with Respiratory Failure, run by Ain Shams University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound diaphragmatic function (time frame: at days 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.