Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy

October 12, 2023 updated by: Dalia Saad Abd-El Kader

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 .

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12555
        • Sara ABD El-Salam

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C
Control group will received saline
Drug: Saline Solution
Placebo
Other Names:
  • Nacl 0.9 %
Active Comparator: Group L
Levosimendan group will received levosimendan infusion
Drug: Levosimendan
Levosimendan
Active Comparator: Group M
Levosimendan and Magnesium sulphate group will received both drugs
Drug: Levosimendan
Levosimendan
Drug: Magnesium Sulfate
Magnesium Sulfate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dalia Saad Abd-El Kader

Collaborators

Cairo University

Investigators

  • Study Chair: Amel HY Abelala, professor, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2021

Primary Completion (Actual)

March 30, 2023

Study Completion (Actual)

April 30, 2023

Study Registration Dates

First Submitted

March 30, 2020

First Submitted That Met QC Criteria

March 31, 2020

First Posted (Actual)

April 1, 2020

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 12, 2023

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD-223-2019

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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