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Completed

NCT Number: NCT04330755

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

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 .

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Key information

Conditions

Aortic Coarctation Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sara ABD El-Salam

Cairo, 12555, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline Solution

Drug

Placebo

Other names: Nacl 0.9 %

Levosimendan

Drug

Levosimendan

Magnesium sulfate

Drug

Magnesium Sulfate

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Dalia Saad Abd-El Kader

Other

Collaborators

  • Cairo University

Registry information

Official study 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.

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 1, 2020
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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