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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PS alone group | No Intervention | Patients received only Protamine Sulfate for reversal of Heparin | |
| PS and HC group | Experimental | Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrocortisone 200mg IV | Drug | single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mustafa A Alrabayah, MD | The University of Jordan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine | Zarqa | 13133 | Jordan |
decision depends on the roles and regulations of The University of Jordan
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
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Randomization envelopes kept closed until the completion of patient registration.
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 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |