The Role of Hydrocortisone Per-treatment in Decreasing Side Effects of Protamine Sulfate During Cardiac Surgeries, a Randomized Control Trial.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Randomization envelopes kept closed until the completion of patient registration.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
PS and HC group
Patients received Hydrocortisone pre-treatment then Protamine Sulfate for the reversal of Heparine
干预措施: Hydrocortisone 200mg IV (Drug)
结局指标
主要结局
Blood pressure
时间窗: 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
次要结局
- Hemodynamic parameters(the change in drugs doses required to maintain mean arterial pressure more than 65 mmHg during the first 30 minutes following Protamine dose)
研究者
Mustafa Alrabayah
Assistant Professor
University of Jordan
