Aims

Sepsis and septic shock are common causes of hospitalization and mortality in patients with cirrhosis. There is no data on the choice of fluid and resuscitation protocols in sepsis-induced hypotension in cirrhosis.

Methods

In this open-label trial conducted at a single center, we enrolled 308 cirrhotics with sepsis-induced hypotension and randomized them to receive either 5% albumin or normal saline. The primary endpoint was a reversal of hypotension [mean arterial pressure, MAP, ≥ 65 mmHg] at 3 h. Secondary endpoints included serial effects on heart rate, arterial lactate and urine output.

Results

154 patients each received 5% albumin (males, 79.8%, mean MAP 52.9 ± 7.0 mm Hg) or 0.9% saline (85.1%, 53.4 ± 6.3 mm Hg) with comparable baseline parameters and liver disease severity. Reversal of hypotension was higher in patients receiving 5% albumin than saline at the end of one hour [25.3% and 11.7%, p = 0.03, Odds ratio (95% CI)—1.9 (1.08–3.42)] and at the end of three hours [11.7% and 3.2%, p = 0.008, 3.9 (1.42–10.9)]. Sustained reduction in heart rate and hyperlactatemia (p < 0.001) was better in the albumin group. At one week, the proportion of patients surviving was higher in the albumin group than those receiving saline (43.5% vs 38.3%, p = 0.03). Female gender and SOFA ≥ 11 were predictors of non-response to fluid.

Conclusions

5% human albumin is safe and beneficial in reversing sepsis-induced hypotension compared to normal saline in patients with cirrhosis improving clinically assessable parameters of systemic hemodynamics, tissue perfusion and in-hospital short-term survival of cirrhosis patients with sepsis.

Graphic abstract

中文翻译：

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5% 人白蛋白和生理盐水在肝硬化患者脓毒症引起的低血压中液体复苏的比较（FRISC 研究）：一项随机对照试验

宗旨

脓毒症和感染性休克是肝硬化患者住院和死亡的常见原因。没有关于在脓毒症引起的肝硬化低血压中选择液体和复苏方案的数据。

方法

在这项在单中心进行的开放标签试验中，我们招募了 308 名患有败血症引起的低血压的肝硬化患者，并将他们随机分配接受 5% 白蛋白或生理盐水。主要终点是在 3 小时时逆转低血压 [平均动脉压，MAP，≥ 65 mmHg]。次要终点包括对心率、动脉乳酸和尿量的连续影响。

结果

154 名患者每人接受 5% 白蛋白（男性，79.8%，平均 MAP 52.9 ± 7.0 毫米汞柱）或 0.9% 生理盐水（85.1%，53.4 ± 6.3 毫米汞柱），基线参数和肝脏疾病严重程度相当。一小时结束时接受 5% 白蛋白治疗的患者的低血压逆转率高于生理盐水 [25.3% 和 11.7%，p  = 0.03，优势比 (95% CI)—1.9 (1.08–3.42)] 和治疗结束时三小时 [11.7% 和 3.2%，p  = 0.008, 3.9 (1.42–10.9)]。 白蛋白组心率和高乳酸血症的持续降低（p < 0.001）更好。一周后，白蛋白组患者的存活率高于生理盐水组（43.5% 对 38.3%，p  = 0.03）。女性和 SOFA ≥ 11 是对液体无反应的预测因素。

结论

在肝硬化患者中，与生理盐水相比，5% 人白蛋白在逆转脓毒症引起的低血压方面是安全且有益的，可改善临床上可评估的全身血流动力学参数、组织灌注和脓毒症肝硬化患者的院内短期存活率。

图形摘要