High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease
1 other identifier
interventional
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Oct 2021
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 16, 2021
CompletedFirst Submitted
Initial submission to the registry
October 22, 2021
CompletedFirst Posted
Study publicly available on registry
November 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2022
CompletedNovember 2, 2021
October 1, 2021
3 months
October 22, 2021
November 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
assessment of Level of IL 6 after CPB time
comparing level of IL6 in different groups after CPB
3 months
Secondary Outcomes (1)
Less postoperative complications related to high doses of steroid represented as blood glucose level.
3 months
Study Arms (3)
low dose group
ACTIVE COMPARATORlow dose group. Group (A) (25 patients) patients will receive 10 mg/Kg methyl prednisolone after induction before separation to (CPB).
high dose group
ACTIVE COMPARATORhigh dose group. Group (B) (25 patients) patients will receive 30 mg/Kg methyl prednisolone after induction before separation to (CPB).
Placebo group
PLACEBO COMPARATORplacebo group. Group (C) (control group)(25 patients) patients will receive placebo in form of normal saline.
Interventions
Low dose group .Group (A) 10 mg/Kg methyl prednisolone will be received after induction and before separation to (CPB).
High dose group.Group (B) 30 mg/Kg will be received after induction and before separation (CPB)
Placebo group.Group (C) (25 patients) patients will receive placebo in form of normal saline
Eligibility Criteria
You may qualify if:
- We will include pediatric patients ( 1- 16) years old undergoing surgical correction for congenital acyanotic cardiac lesions needing cardiopulmonary bypass machine.
You may not qualify if:
- \) Cyanotic heart disease. 2) Closed cardiac surgeries. 3) Previous cardiac surgery. 4) Patients suffering neurological illness. 5) Diabetics. 6) Emergency procedures. 7) Patients on preoperative steroid therapy. 8) Adult patients with congenital heart disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samar mohammed
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer of anesthesia
Study Record Dates
First Submitted
October 22, 2021
First Posted
November 2, 2021
Study Start
October 16, 2021
Primary Completion
January 15, 2022
Study Completion
January 30, 2022
Last Updated
November 2, 2021
Record last verified: 2021-10