A Phase 4 interventional study of Saline Solution and Levosimendan in Aortic Coarctation, sponsored by Dalia Saad Abd-El Kader. Completed at 1 site in Egypt. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2023-10-16.
Sponsored by Dalia Saad Abd-El Kader · Phase 4, Interventional, and Other
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 .
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 .
49 studies on the registry are indexed under Aortic Coarctation; 16 are open to participants now.
This study's enrollment of 40 is below the median of 45 across 19 interventional studies indexed under Aortic Coarctation.
Browse Aortic Coarctation studies →This is the only study on the registry with Dalia Saad Abd-El Kader as lead sponsor.
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Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction
Exclusion Criteria:
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
Control group will received saline
Drug: Saline Solution
Levosimendan group will received levosimendan infusion
Drug: Levosimendan
Levosimendan and Magnesium sulphate group will received both drugs
Drug: Levosimendan · Drug: Magnesium Sulfate
Placebo
Also known as: Nacl 0.9 %
Levosimendan
Magnesium Sulfate
Near Infrared Spectroscopy value
After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate.
Time frame: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)
This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Simendan · Magnesium Sulfate