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临床试验/NCT04435912
NCT04435912已完成早期 1 期

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

University of Jordan1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年7月4日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mustafa Alrabayah

Assistant Professor

University of Jordan

研究点 (1)

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