Back to resultsLevosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
Primary Purpose
Aortic Coarctation
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Saline Solution
Levosimendan
Magnesium Sulfate
Sponsored by
About this trial
This is an interventional other trial for Aortic Coarctation
Eligibility Criteria
Inclusion Criteria:
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
Sites / Locations
- Sara ABD El-Salam
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Group C
Group L
Group M
Arm Description
Control group will received saline
Levosimendan group will received levosimendan infusion
Levosimendan and Magnesium sulphate group will received both drugs
Outcomes
Primary Outcome Measures
Near Infrared Spectroscopy value
After aortic cross clamping to compare the spinal cord protective effect of levosimendan versus its combination with magnesium sulphate.
Secondary Outcome Measures
Full Information
NCT ID
NCT04330755
First Posted
March 30, 2020
Last Updated
October 12, 2023
Sponsor
Dalia Saad Abd-El Kader
Collaborators
Cairo University
1. Study Identification
Unique Protocol Identification Number
NCT04330755
Brief Title
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
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.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 4, 2021 (Actual)
Primary Completion Date
March 30, 2023 (Actual)
Study Completion Date
April 30, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dalia Saad Abd-El Kader
Collaborators
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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 .
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Coarctation
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C
Arm Type
Placebo Comparator
Arm Description
Control group will received saline
Arm Title
Group L
Arm Type
Active Comparator
Arm Description
Levosimendan group will received levosimendan infusion
Arm Title
Group M
Arm Type
Active Comparator
Arm Description
Levosimendan and Magnesium sulphate group will received both drugs
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
Nacl 0.9 %
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Levosimendan
Intervention Description
Levosimendan
Intervention Type
Drug
Intervention Name(s)
Magnesium Sulfate
Intervention Description
Magnesium Sulfate
Primary Outcome Measure Information:
Title
Near Infrared Spectroscopy value
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amel HY Abelala, professor
Organizational Affiliation
Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Sara ABD El-Salam
City
Cairo
ZIP/Postal Code
12555
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
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