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

November 1, 2021 updated by: maha sadek El Derh, Ain Shams University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective, randomized controlled trial, at Ain Shams University hospitals, Cardiovascular surgery hospital (cardiac surgery unit), Cairo, Egypt.

All patients' legal guardians will sign written informed consent before inclusion.

Randomization will be performed using a computer-generated randomization sequence.

Complete blood count, coagulation tests will be performed for all patients prior to the planned procedure. For all patients included in this study preoperative evaluation including a complete airway evaluation (mouth opening, mallampatii grading, thyromental distance, and evaluation of dentition) will be performed. Standard fasting guidelines will be checked. (Barash PG et al., 2006).

On patient's arrival to operating room, either inhalational induction by sevoflurane 4-6 % followed by an intravenous (IV) line insertion or IV induction by Ketamine 1-2 mg /kg and 0.01 mg / kg Atropine. Standard monitoring including electrocardiography (ECG), pulse oximetry (SpO2). Anesthesia technique: fentanyl 1-5 microgram/kg, will be given during mask preoxygenation with 100% oxygen, followed by non-depolarizing muscle relaxant (atracurium 0.5 mg /Kg) and then endotracheal intubation and capnography will be applied (Barash PG et al., 2006).

Femoral artery cannulation by 20 G Leader catheter cannula for invasive blood pressure (BP)measurement, triple lumen central line will be inserted in internal jugular vein (BRAUN) by ultrasound guided technique.

After achievement of anesthesia and full muscle relaxation and intubation of the airway, a blood sample ( 2 ml) will be taken to measure (IL6), Troponin I and blood glucose level. Skin incision will take place followed by median sternotomy. Heparin 300-500 IU/kg will be given before aortic cannulation to achieve ACT of 450-480 before starting CPB. Patients will then be divided into 3 groups:

Group (A) (25 patients) patients will receive 10 mg/Kg methyl prednisolone after induction before separation to (CPB). (Schroeder et al.,2003).

Group (B) (25 patients) patients will receive 30 mg/Kg methyl prednisolone after induction before separation to (CPB). (Keski-Nisula et al., 2013).

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

We will study the different doses of methylprednisolone as there is no standard dose confirmed in pediatric cardiac surgery. We will compare the low dose with high dose of this drug to decrease the different side effects of steroids, and we will detect the efficacy by measuring the inflammatory markers. In our institute the IL 6 is the only available marker to be measured.

The attending doctor will not give the drug, as another doctor not attending the surgery will give it. Both the attending doctor and intensivist will be blinded to the drug given.

After surgical correction of cardiac lesion and separation of cardiopulmonary bypass machine, support of the heart will be achieved and maintained by millirone 0.3-0.7 ug/Kg/min together with noradrenaline0.01-1 ug/Kg/min. Reversal of heparin by protamine sulphate 1:1 correction. Vital data, blood pressure and heart rate will be recorded every 10 minutes, the need or the dose of vasopressors needed will be recorded. After hemostasis and chest closure, patients will be transferred to ICU (Barash PG et al., 2006).

After admission to ICU, stabilization of patient, another blood sample of (2 ml) to measure (IL6) , troponin and random blood sugar will be taken, and a third sample will be withdrawn after 24 hours. Vital data will be recorded every 30 minutes till extubation. Time of extubation will be recorded. Complications like neurological events, occurrence of new arrhythmia, wound infection, ICU stay and mortality in the first seven days postoperative will also be recorded.

Study Type

Interventional

Enrollment (Anticipated)

75

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
        • Recruiting
        • Samar Mohammed
        • Contact:
        • Contact:
        • Principal Investigator:
          • maha S elDerh, lecturer

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 year to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • We will include pediatric patients ( 1- 16) years old undergoing surgical correction for congenital acyanotic cardiac lesions needing cardiopulmonary bypass machine.

Exclusion Criteria:

  • 1) 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.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: low dose group
low dose group. Group (A) (25 patients) patients will receive 10 mg/Kg methyl prednisolone after induction before separation to (CPB).
Drug: methyl prednisolone
Low dose group .Group (A) 10 mg/Kg methyl prednisolone will be received after induction and before separation to (CPB).
Other Names:
  • steroid
Active Comparator: high dose group
high dose group. Group (B) (25 patients) patients will receive 30 mg/Kg methyl prednisolone after induction before separation to (CPB).
Drug: Methyl Prednisolonate
High dose group.Group (B) 30 mg/Kg will be received after induction and before separation (CPB)
Other Names:
  • steroid
Placebo Comparator: Placebo group
placebo group. Group (C) (control group)(25 patients) patients will receive placebo in form of normal saline.
Drug: Placebo
Placebo group.Group (C) (25 patients) patients will receive placebo in form of normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of Level of IL 6 after CPB time
Time Frame: 3 months
comparing level of IL6 in different groups after CPB
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Less postoperative complications related to high doses of steroid represented as blood glucose level.
Time Frame: 3 months
comparing Less postoperativecomplications related to high doses of steroid represented as blood glucose level.
3 months

Collaborators and Investigators

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

Sponsor

Ain Shams 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)

October 16, 2021

Primary Completion (Anticipated)

January 15, 2022

Study Completion (Anticipated)

January 30, 2022

Study Registration Dates

First Submitted

October 22, 2021

First Submitted That Met QC Criteria

November 1, 2021

First Posted (Actual)

November 2, 2021

Study Record Updates

Last Update Posted (Actual)

November 2, 2021

Last Update Submitted That Met QC Criteria

November 1, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMASU R 171/2021

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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