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High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease

NCT05103397 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-11-02

No results posted yet for this study

Summary

To compare the effect of low dose methylprednisolone versus high dose on inflammatory mediators' level and cardioprotective effect after CPB in correction of congenital acyanotic heart disease.

Conditions

  • Anesthesia

Interventions

DRUG

methyl prednisolone

Low dose group .Group (A) 10 mg/Kg methyl prednisolone will be received after induction and before separation to (CPB).

DRUG

Methyl Prednisolonate

High dose group.Group (B) 30 mg/Kg will be received after induction and before separation (CPB)

DRUG

Placebo

Placebo group.Group (C) (25 patients) patients will receive placebo in form of normal saline

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-16
Primary Completion
2022-01-15
Completion
2022-01-30

Countries

  • Egypt

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103397 on ClinicalTrials.gov