Airway Pressure, Blood Pressure, Heart Rate
Conditions
Keywords
Protamine sulfate, Hydrocortisone, Protamine Sulfate side effects
Brief summary
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
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.
Interventions
DRUGHydrocortisone 200mg IV
single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine
Sponsors
University of Jordan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Randomization envelopes kept closed until the completion of patient registration.
Intervention model description
Parallel group, randomized, controlled trial with 1:1 allocation ratio. Participants were Patients undergoing cardiac surgery using cardiopulmonary bypass.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure | changes of baseline blood pressure taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given | both systolic, diastolic and mean arterial pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamic parameters | changes of baseline readings taken preoperatively and readings taken during 30 minutes after Protamine Sulfate was given | Heart rate (Beat Per Minute), |
Countries
Jordan
Outcome results
None listed