跳至主要内容
临床试验/NCT06322537
NCT06322537进行中(未招募)不适用

Albumin Utilization for Intravascular Volume Replacement in Adult Cardiac Surgical Patients : A Multi-centre, Retrospective, Cohort Study

University Health Network, Toronto10 个研究点 分布在 1 个国家目标入组 505 人开始时间: 2024年5月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
505
试验地点
10
主要终点
Albumin

研究概览

简要总结

All heart surgery patients universally require hydration, which is given through a vein in the arm, but practices for treating patients are not universal. There are disagreements about whether crystalloids should be used alone or in combination with albumin. This question has important implications because albumin is an expensive blood product in relatively limited supply, and 20% of its use is by heart surgery patients. The goal of this study is to learn more about how crystalloids and albumin are used during heart surgery, as well as, key patient outcomes.

详细描述

The goal of this proposed multicentre retrospective cohort study is to characterize perioperative usage patterns of crystalloids and albumin, as well as key patient outcomes, in cardiac surgical patients. This study will also address numerous other knowledge gaps in the area of perioperative blood product management and fluid administration in cardiac surgery and define a collaborative group to support future research in this field.

The primary objective is to obtain granular information on if, when, and how albumin is given perioperatively to cardiac surgical patients. This includes the doses and settings in which albumin is used, the types of crystalloid solutions (balanced or unbalanced) used, and when albumin is used (for example, while on cardio-pulmonary bypass, in the ICU, or on the ward) in perioperative cardiac surgical care across institutions. This important information about the scope of albumin and crystalloid use across the country will inform the design of our future intervention and control arms in the planned definitive trial.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adult (≥18 years old)
  • •Cardiac surgery with the use of cardiopulmonary bypass
  • •Cardiac surgery without the use of cardiopulmonary bypass

排除标准

  • 未提供

研究组 & 干预措施

Cardiac Surgery Patients

Adult (≥18 years old) patients who have undergone cardiac surgery.

结局指标

主要结局

Albumin

时间窗: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.

Type, dose and timing of administration, the setting in which it was ordered, indication for use, and the type of provider responsible for the patient at administration (surgeon, anesthesiologist, intensivist, nurse practitioner).

Crystalloid, volume dose and type administered

时间窗: On CPB, in the operating room but not during CPB, in the ICU, on the ward to post operative day 28.

Type and volume of crystalloid given (Normal saline, Ringer's Lactate, Plasmalyte-148, and others), as well as the setting of administration will be recorded.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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