Hydrocortisone Per-treatment Decrease Side Effects of Protamine Sulfate

Study Overview
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Brief Summary
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This study aims to compare the hemodynamic parameters within and between patients who received Protamine Sulfate (PS) with Hydrocortisone (HC) vs. Protamine Sulfate alone during cardiac surgeries.

Detailed Description
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the investigators hypothesized that patients received PS along with HC would have different results in intraoperative hemodynamic changes of the blood pressure - both Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Mean Arterial Pressure (MAP) reading. Differences would also be expected for Heart rate (HR), Airway pressure and the usage of Adrenaline, Noradrenaline and Dobutamine. Patients who had cardiac surgery using cardiopulmonary bypass were screened and enrolled from 4/7/2019 to 30/4/2020. Inclusion criteria for patients were normal preoperative hemoglobin level, normal preoperative platelet count, no known defect of the coagulation system, and patients with unimpaired renal function (creatinine clearance < 30 ml/kg/min). The patients were excluded if they were younger than 18 years, patients with known defect of the coagulation system, renal impairment, previous vasectomy, allergy to fish or unable to give consent form. The study carried out as a parallel-group, randomized, controlled trial with a 1:1 allocation ratio. Patients were screened for eligibility in the wards before being invited to participate in the research. After the invitation, the study was explained to patients. Those who agreed to participate in the study were asked to sign the consent form.

Official Title
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The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.

Conditions
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Blood Pressure, Heart Rate, Airway Pressure

Intervention / Treatment
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* Drug: Hydrocortisone 200mg IV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had cardiac surgery using cardiopulmonary bypass Normal preoperative hemoglobin level Normal preoperative platelet count No known defect of the coagulation system Patients with unimpaired renal function (creatinine clearance < 30 ml/kg/min) Exclusion Criteria: Patients younger than 18 years Patients with known defect of the coagulation system Renal impairment Previous vasectomy Allergy to fish Unable to give consent form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: PS alone group<br>Patients received only Protamine Sulfate for reversal of Heparin | |
| Experimental: PS and HC group<br>Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine | Drug: Hydrocortisone 200mg IV<br>* single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | both systolic, diastolic and mean arterial pressure | changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic parameters | Heart rate (Beat Per Minute), | changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given | 
| Hemodynamic parameters | Airway pressure (cm H2O) | changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given | 
| Hemodynamic parameters | The usage of Adrenaline, Noradrenaline and Dobutamine (microgram/kg/min). | the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Protamine sulfate, Hydrocortisone, Protamine Sulfate side effects