一项评估改良超滤作为心脏手术中血液保护技术的可行性的多中心随机对照试验。

A multicenter randomized controlled trial to assess the feasibility of testing modified ultrafiltration as a blood conservation technology in cardiac surgery.

机构信息

Division of Cardiac Surgery, University of Ottawa Heart Institute, Ottowa, Ontario K1Y 4W7, Canada.

出版信息

J Thorac Cardiovasc Surg. 2010 Mar;139(3):701-6. doi: 10.1016/j.jtcvs.2009.11.056.

DOI:10.1016/j.jtcvs.2009.11.056

PMID:20176212

Abstract

OBJECTIVES

Modified ultrafiltration is a technique after cardiopulmonary bypass whereby blood withdrawn from the aortic cannula is passed across a semipermeable membrane to hemoconcentrate. Unblinded trials have suggested that modified ultrafiltration is efficacious for blood conservation. The objective of this trial was to assess the feasibility of a model testing modified ultrafiltration in which all members of the surgical team were blinded to the intervention.

METHODS

Patients (<65kg) undergoing procedures involving cardiopulmonary bypass were randomized to undergo either modified ultrafiltration (n=29) or sham (circulation without an interposed filter, n=36) for 15minutes. The circuit was shielded from all members of the team except the perfusionist. A questionnaire was administered to determine the blinding success.

RESULTS

Modified ultrafiltration resulted in a removal of 1000+/-251mL of fluid and a reduction in the pump balance (1025+/-807 vs 1804+/-838; P < .001) with an increase in hemoglobin immediately after intervention (increase of 7.7+/-8.8g/L in modified ultrafiltration vs 3.8+/-5.1g/L in sham; P=.04). Introduction or increase in dose of vasopressors was more frequent in the modified ultrafiltration group (52% vs 28%; P=.048). Differences in red cell transfusion rates between groups did not reach statistical significance (P=.59). Blinding was successful for the anesthetist (blinding index 0.13 [95% confidence interval, 0.11-0.38] and the intensivist (blinding index, 0.09 [95% confidence interval, 0.14-0.31]) but not for the surgeon (blinding index, 0.24 [95% confidence interval, 0.05-0.42]). The compliance rate for the transfusion protocol was greater than 90%.

CONCLUSIONS

Modified ultrafiltration was effective for hemoconcentration after cardiopulmonary bypass in patients of low body weight, but it is associated with an increased need for vasopressor support. The anesthetist and intensivist were successfully blinded to the intervention.

摘要

目的

体外循环后采用改良超滤技术，将从主动脉插管中抽出的血液通过半透膜，使血液浓缩。非盲法试验表明改良超滤对于血液保护是有效的。本试验的目的是评估一种模型测试改良超滤的可行性，其中所有手术团队成员对干预均设盲。

方法

<65kg 的患者在接受体外循环手术时，随机接受改良超滤（n=29）或假手术（循环无插入式过滤器，n=36）15 分钟。该回路被屏蔽，除灌注师外，所有团队成员都无法看到。进行问卷调查以确定盲法的成功率。

结果

改良超滤可去除 1000+/-251ml 的液体，并减少泵平衡（1025+/-807 与 1804+/-838；P<.001），干预后血红蛋白立即升高（改良超滤组增加 7.7+/-8.8g/L，假手术组增加 3.8+/-5.1g/L；P=.04）。改良超滤组更频繁地使用血管加压药（52%与 28%；P=.048）。两组间红细胞输血率的差异未达到统计学意义（P=.59）。麻醉师（盲法指数 0.13[95%置信区间，0.11-0.38]）和重症监护医生（盲法指数，0.09[95%置信区间，0.14-0.31]）的盲法成功，但外科医生（盲法指数，0.24[95%置信区间，0.05-0.42]）的盲法不成功。输血方案的顺应率大于 90%。