心脏手术后围手术期目标导向血流动力学复苏治疗对结局的影响：一项随机临床试验和系统评价。

Effect of Perioperative Goal-Directed Hemodynamic Resuscitation Therapy on Outcomes Following Cardiac Surgery: A Randomized Clinical Trial and Systematic Review.

机构信息

1Surgical Intensive Care Unit and Department of Anesthesiology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil. 2Department of Intensive Care Medicine, St George's Healthcare NHS Trust and St George's University of London, London, United Kingdom. 3Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute and Vita-Salute San Raffaele Scientific Institute, Milan, Italy. 4Department of Anesthesiology and Intensive Care, Friedrich Schiller University Hospital, Jena University, Jena, Germany. 5Department of Cardiopneumology, Heart Institute (InCor), Hospital das Clinicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil.

出版信息

Crit Care Med. 2016 Apr;44(4):724-33. doi: 10.1097/CCM.0000000000001479.

DOI:10.1097/CCM.0000000000001479

PMID:26646462

Abstract

OBJECTIVES

To evaluate the effects of goal-directed therapy on outcomes in high-risk patients undergoing cardiac surgery.

DESIGN

A prospective randomized controlled trial and an updated metaanalysis of randomized trials published from inception up to May 1, 2015.

SETTING

Surgical ICU within a tertiary referral university-affiliated teaching hospital.

PATIENTS

One hundred twenty-six high-risk patients undergoing coronary artery bypass surgery or valve repair.

INTERVENTIONS

Patients were randomized to a cardiac output-guided hemodynamic therapy algorithm (goal-directed therapy group, n = 62) or to usual care (n = 64). In the goal-directed therapy arm, a cardiac index of greater than 3 L/min/m was targeted with IV fluids, inotropes, and RBC transfusion starting from cardiopulmonary bypass and ending 8 hours after arrival to the ICU.

MEASUREMENTS AND MAIN RESULTS

The primary outcome was a composite endpoint of 30-day mortality and major postoperative complications. Patients from the goal-directed therapy group received a greater median (interquartile range) volume of IV fluids than the usual care group (1,000 [625-1,500] vs 500 [500-1,000] mL; p < 0.001], with no differences in the administration of either inotropes or RBC transfusions. The primary outcome was reduced in the goal-directed therapy group (27.4% vs 45.3%; p = 0.037). The goal-directed therapy group had a lower occurrence rate of infection (12.9% vs 29.7%; p = 0.002) and low cardiac output syndrome (6.5% vs 26.6%; p = 0.002). We also observed lower ICU cumulative dosage of dobutamine (12 vs 19 mg/kg; p = 0.003) and a shorter ICU (3 [3-4] vs 5 [4-7] d; p < 0.001) and hospital length of stay (9 [8-16] vs 12 [9-22] d; p = 0.049) in the goal-directed therapy compared with the usual care group. There were no differences in 30-day mortality rates (4.8% vs 9.4%, respectively; p = 0.492). The metaanalysis identified six trials and showed that, when compared with standard treatment, goal-directed therapy reduced the overall rate of complications (goal-directed therapy, 47/410 [11%] vs usual care, 92/415 [22%]; odds ratio, 0.40 [95% CI, 0.26-0.63]; p < 0.0001) and decreased the hospital length of stay (mean difference, -5.44 d; 95% CI, -9.28 to -1.60; p = 0.006) with no difference in postoperative mortality: 9 of 410 (2.2%) versus 15 of 415 (3.6%), odds ratio, 0.61 (95% CI, 0.26-1.47), and p = 0.27.

CONCLUSIONS

Goal-directed therapy using fluids, inotropes, and blood transfusion reduced 30-day major complications in high-risk patients undergoing cardiac surgery.

摘要

目的

评估目标导向治疗对高危心脏手术患者结局的影响。

设计

前瞻性随机对照试验和截至 2015 年 5 月 1 日发表的随机试验的更新荟萃分析。

地点

三级转诊大学附属医院的外科重症监护病房。

患者

126 例高危行冠状动脉旁路移植术或瓣膜修复术的患者。

干预措施

患者随机分为心输出量导向的血流动力学治疗算法（目标导向治疗组，n = 62）或常规治疗（n = 64）。在目标导向治疗组中，从体外循环开始并在到达 ICU 后 8 小时结束，以静脉输液、正性肌力药物和红细胞输注将心指数目标设定为大于 3 L/min/m。

测量和主要结果

主要终点为 30 天死亡率和主要术后并发症的复合终点。与常规治疗组相比，目标导向治疗组接受了更多的中位（四分位距）静脉输液（1000 [625-1500] 与 500 [500-1000] mL；p < 0.001），而正性肌力药物或红细胞输注的使用无差异。与常规治疗组相比，目标导向治疗组的主要结局降低（27.4%与 45.3%；p = 0.037）。目标导向治疗组感染发生率（12.9%与 29.7%；p = 0.002）和低心输出综合征（6.5%与 26.6%；p = 0.002）的发生率较低。我们还观察到目标导向治疗组 ICU 累积多巴酚丁胺剂量（12 与 19 mg/kg；p = 0.003）和 ICU 住院时间（3 [3-4] 与 5 [4-7] d；p < 0.001）以及住院时间（9 [8-16] 与 12 [9-22] d；p = 0.049）均较短。两组 30 天死亡率无差异（分别为 4.8%与 9.4%；p = 0.492）。荟萃分析确定了六项试验，结果表明与标准治疗相比，目标导向治疗降低了总体并发症发生率（目标导向治疗组，47/410 [11%] 与常规治疗组，92/415 [22%]；比值比，0.40 [95%置信区间，0.26-0.63]；p < 0.0001），缩短了住院时间（平均差值，-5.44 d；95%置信区间，-9.28 至-1.60；p = 0.006），但术后死亡率无差异：410 例中的 9 例（2.2%）与 415 例中的 15 例（3.6%），比值比，0.61（95%置信区间，0.26-1.47），p = 0.27。