Aortic CoarctationPhase 4NCT04330755
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
A Phase 4 study testing Saline Solution, Levosimendan and Magnesium Sulfate in people with Aortic Coarctation, run by Dalia Saad Abd-El Kader at 1 site in Egypt.
Trial summary
In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate . Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Aortic Coarctation
- What is being tested?
- Saline Solution, Levosimendan and Magnesium Sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Feb 2021to 30 Apr 2023
- 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 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction
Who cannot join
- Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Levosimendan Versus Its Combination to Magnesium Sulphate on Spinal Cord Protection Guided by NIRS in Infants Undergoing Coarctectomy: A Randomized Controlled Study.
In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .
Read the detailed description
Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .
- Conditions
- Aortic Coarctation
- Being tested
- Saline Solution, Levosimendan, Magnesium Sulfate
- Medical subject headings
- Aortic Coarctation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline SolutionDrug
Also called Nacl 0.9 %
Placebo
LevosimendanDrug
Levosimendan
Magnesium SulfateDrug
Magnesium Sulfate
| Study group | Role | What they receive |
|---|---|---|
| Group C | Placebo comparator | Control group will received saline Receives: Drug: Saline Solution |
| Group L | Active comparator | Levosimendan group will received levosimendan infusion Receives: Drug: Levosimendan |
| Group M | Active comparator | Levosimendan and Magnesium sulphate group will received both drugs Receives: Drug: Levosimendan; Drug: Magnesium Sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near Infrared Spectroscopy value
After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate.
Measured: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start4 Feb 2021
- Primary completion30 Mar 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic CoarctationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dalia Saad Abd-El Kader
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Dalia Saad Abd-El Kader, Kasr El Aini Hospital
- Investigators
- Amel HY Abelala, professor, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330755
- Sponsor's protocol ID
- MD-223-2019
- Status last verified
- Apr 2021
- First submitted
- 30 Mar 2020
- Last updated
- 16 Oct 2023
- 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 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Levosimendan Versus Its Combination to Magnesium Sulphate on Spinal Cord Protection Guided by NIRS in Infants Undergoing Coarctectomy: A Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT04330755
- Acronym / sponsor ID
- MD-223-2019
- Conditions
- Aortic Coarctation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dalia Saad Abd-El KaderUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 4 Feb 2021 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 1 Apr 2020 (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.
In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .
Detailed description
Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group C | Placebo comparator | Drug: Saline SolutionControl group will received saline |
| Group L | Active comparator | Drug: LevosimendanLevosimendan group will received levosimendan infusion |
| Group M | Active comparator | Drug: Levosimendan, Drug: Magnesium SulfateLevosimendan and Magnesium sulphate group will received both drugs |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction
Key exclusion criteria (1 listed)
- Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction
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 |
|---|---|---|
| Saline SolutionAlso: Nacl 0.9 %Placebo | Drug | Group C |
| LevosimendanLevosimendan | Drug | Group L, Group M |
| Magnesium SulfateMagnesium Sulfate | Drug | Group M |
Primary outcome
Near Infrared Spectroscopy value
Time frame: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)
After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate.
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 16 Oct 2023.
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Morality
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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.
Amel HY Abelala, professor study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline Solution, Levosimendan and Magnesium Sulfate in people with Aortic Coarctation, run by Dalia Saad Abd-El Kader at 1 site 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 1 inclusion and 1 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 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Near Infrared Spectroscopy value (time frame: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)). 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 16 Oct 2023.