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临床试验/NCT04839432
NCT04839432已完成不适用

Effect of 4% Albumin Prime Solution for Cardiopulmonary Bypass on Postoperative Pulmonary Complications In Patients Undergoing Pulmonary Endarterectomy: A Propensity-adjusted Analysis

Erasme University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
1
主要终点
pulmonary complications

研究概览

简要总结

In 2019, the investigators initiated a new priming fluid therapy strategy in the cardiopulmonary bypass (CPB) machine for patients undergoing pulmonary endarterectomy surgery. It consisted in a transition from a "pure" primarly balanced crystalloid priming fluid strategy to a 4% human albumin priming fluid-strategy in addition to a low volume of balanced crystalloid solution. The rationale was the theoritical assumption that albumin leads to better intravascular volume expansion compared to crystalloid and therefore could reduce overall volume requirement during surgery and consequently potentially decrease the incidence of postoperative pulmonary complications. The objective of this propensity-matched study was to evaluate the effectiveness of this intervention

详细描述

Intravenous fluid is usually needed (and sometime in important amount) to increase intravascular volume during cardiac surgery and to prime the cardiopulmonary bypass (CPB) circuit. In this context, albumin has been frequently used as the ideal fluid choice. Although albumin has the disadvantage to be much more expensive than crystalloids and not to be free from immunological reactions, this solution provides a more sustained volume effect that a similar volume of crystalloid which may result in smaller volumes of resuscitation fluid being administered. It also better preserves the on-bypass oncotic pressure and reduce extravascular lung water. These considerations are important especially during pulmonary thromboendarterectomy surgery (PTE), a high-risk procedure which aims to resect thromboembolic material. Reperfusion lung injury (RLI) and/or acute respiratory distress syndrome (ARDS), are the most encountered postoperative pulmonary complications and are significant risks factors of morbi-mortality. As data suggest that RLI and ARDS are high-permeability phenomenon, cautious is required to avoid fluid accumulation/overload during this complex procedure. In addition, this surgical procedure has a relatively high CPB duration which can induce a systemic inflammatory response syndrome, damage the endothelial glycocalyx and vascular barrier where crystalloids may extravagates and accumulates in the lungs. On the contrary, albumin solution used during the priming of CPB can favorably preserve oncotic pressure, have a protective effect on endothelial glycocalyx and better maintain vascular barrier competence, preventing interstitial edema and potential pulmonary complications.

In March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of pulmonary complications observed in the investigators patients.

The objective of this propensity-matched study was to evaluate the effectiveness of this intervention

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

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

入选标准

  • All consecutive patients undergoing pulmonary endarterectomy surgery

排除标准

  • Patients with important missing data
  • Patients undergoing combined surgery
  • Patients undergoing an emergency pulmonary endarterectomy surgery

结局指标

主要结局

pulmonary complications

时间窗: postoperative day 7

a composite of two pulmonary complications ( reperfusion lung syndrome and/or acute respiratory distress syndrome)

次要结局

未报告次要终点

研究者

发起方
Erasme University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Joosten, MD PhD

Study Director

Erasme University Hospital

研究点 (1)

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