NCT04330755

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Feb 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 1, 2020

Completed
10 months until next milestone

Study Start

First participant enrolled

February 4, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

October 16, 2023

Status Verified

April 1, 2021

Enrollment Period

2.1 years

First QC Date

March 30, 2020

Last Update Submit

October 12, 2023

Conditions

Aortic Coarctation

Outcome Measures

Primary Outcomes (1)

  • Near Infrared Spectroscopy value

    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)

Study Arms (3)

Group C

PLACEBO COMPARATOR

Control group will received saline

Drug: Saline Solution

Group L

ACTIVE COMPARATOR

Levosimendan group will received levosimendan infusion

Drug: Levosimendan

Group M

ACTIVE COMPARATOR

Levosimendan and Magnesium sulphate group will received both drugs

Drug: LevosimendanDrug: Magnesium Sulfate

Interventions

Saline SolutionDRUG

Placebo

Also known as: Nacl 0.9 %
Group C
LevosimendanDRUG

Levosimendan

Group LGroup M
Magnesium SulfateDRUG

Magnesium Sulfate

Group M

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sara ABD El-Salam

Cairo, 12555, Egypt

Location

MeSH Terms

Conditions

Aortic Coarctation

Interventions

Saline SolutionSodium ChlorideSimendanMagnesium Sulfate

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHydrazonesHydrazinesOrganic ChemicalsPyridazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMagnesium CompoundsSulfatesSulfuric AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Amel HY Abelala, professor

    Cairo University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principle investigator

Study Record Dates

First Submitted

March 30, 2020

First Posted

April 1, 2020

Study Start

February 4, 2021

Primary Completion

March 30, 2023

Study Completion

April 30, 2023

Last Updated

October 16, 2023

Record last verified: 2021-04

Locations

EG(1)