Abstract：
Twenty per cent albumin (1.5 g/kg at diagnosis and 1 g/kg on day three, infused over six-hour duration) is recommended particularly in high-risk spontaneous bacterial peritonitis (SBP). Whether reduced dose albumin infusion is as effective as the standard dose albumin infusion is not clear. The aim of this study was to compare standard dose albumin infusion with reduced dose albumin infusion in acute kidney injury (AKI) development or progression in patients with cirrhosis and high-risk SBP.
Sixty-three patients were randomized to the standard dose albumin arm (n = 31) and reduced dose albumin arm (n = 32, 0.75 g/kg at diagnosis and 0.5 g/kg 48 h later). The albumin was infused over six-hour duration in both groups. When the patient developed respiratory distress, the albumin infusion was stopped and that dose (i.e. of day one or day three) was not restarted and no attempt was made to finish the whole dose of that day. However, the next dose was started at the pre-calculated infusion rate if there was no evidence of respiratory distress at the start of next infusion.
All 31 patients in standard dose and two (6.25%) in the reduced dose group developed symptomatic circulatory overload (p < 0.001), with infusions being stopped prematurely. The actual albumin dose received on day one was similar in both groups and only slightly higher in the standard dose group on day three. Resolution of SBP, progression of AKI to higher stage, in-hospital mortality and 28 days\' mortality were similar in both groups.
For treatment of SBP, standard dose albumin infusion (1.5 g/kg at diagnosis and 1 g/kg 48 hours later) infused over six hours is not tolerated by Indian patients. The effectiveness of standard dose albumin infused over more prolonged periods, as compared to reduced dose albumin, should be evaluated in further studies.
Clinical Trials.gov Identifier: NCT04273373 .
Sixty-three patients were randomized to the standard dose albumin arm (n = 31) and reduced dose albumin arm (n = 32, 0.75 g/kg at diagnosis and 0.5 g/kg 48 h later). The albumin was infused over six-hour duration in both groups. When the patient developed respiratory distress, the albumin infusion was stopped and that dose (i.e. of day one or day three) was not restarted and no attempt was made to finish the whole dose of that day. However, the next dose was started at the pre-calculated infusion rate if there was no evidence of respiratory distress at the start of next infusion.
All 31 patients in standard dose and two (6.25%) in the reduced dose group developed symptomatic circulatory overload (p < 0.001), with infusions being stopped prematurely. The actual albumin dose received on day one was similar in both groups and only slightly higher in the standard dose group on day three. Resolution of SBP, progression of AKI to higher stage, in-hospital mortality and 28 days\' mortality were similar in both groups.
For treatment of SBP, standard dose albumin infusion (1.5 g/kg at diagnosis and 1 g/kg 48 hours later) infused over six hours is not tolerated by Indian patients. The effectiveness of standard dose albumin infused over more prolonged periods, as compared to reduced dose albumin, should be evaluated in further studies.
Clinical Trials.gov Identifier: NCT04273373 .
摘要：
目标：20%白蛋白（诊断时1.5g/kg，第3天1g/kg，建议在6小时内输注），特别是在高危自发性细菌性腹膜炎（SBP）中。尚不清楚减少剂量的白蛋白输注是否与标准剂量的白蛋白输注一样有效。这项研究的目的是比较标准剂量白蛋白输注与低剂量白蛋白输注在肝硬化和高危SBP患者急性肾损伤（AKI）发展或进展中的作用。
方法：63例患者随机分为标准剂量白蛋白组（n=31）和低剂量白蛋白组（n=32，诊断时0.75g/kg，48h后0.5g/kg）。两组均在6小时内输注白蛋白。当患者出现呼吸窘迫时，停止白蛋白输注,且未重新开始该剂量(即第1天或第3天),也未尝试完成当天的整个剂量.然而,如果在下一次输注开始时没有呼吸窘迫的证据,则以预先计算的输注速率开始下一次给药.
结果：标准剂量组的所有31例患者和低剂量组的2例患者（6.25％）出现有症状的循环超负荷（p<0.001），过早停止输液。在第1天接受的实际白蛋白剂量在两组中是相似的,在第3天的标准剂量组中仅稍高。SBP的分辨率,AKI进展到更高阶段，两组的住院死亡率和28日死亡率相似.
结论：对于SBP的治疗，印度患者不耐受标准剂量白蛋白输注(诊断时1.5g/kg,48小时后1g/kg)超过6小时.在更长时间内输注标准剂量白蛋白的有效性，与减少剂量的白蛋白相比，应该在进一步的研究中进行评估。
背景：临床试验.gov标识符：NCT04273373。
方法：63例患者随机分为标准剂量白蛋白组（n=31）和低剂量白蛋白组（n=32，诊断时0.75g/kg，48h后0.5g/kg）。两组均在6小时内输注白蛋白。当患者出现呼吸窘迫时，停止白蛋白输注,且未重新开始该剂量(即第1天或第3天),也未尝试完成当天的整个剂量.然而,如果在下一次输注开始时没有呼吸窘迫的证据,则以预先计算的输注速率开始下一次给药.
结果：标准剂量组的所有31例患者和低剂量组的2例患者（6.25％）出现有症状的循环超负荷（p<0.001），过早停止输液。在第1天接受的实际白蛋白剂量在两组中是相似的,在第3天的标准剂量组中仅稍高。SBP的分辨率,AKI进展到更高阶段，两组的住院死亡率和28日死亡率相似.
结论：对于SBP的治疗，印度患者不耐受标准剂量白蛋白输注(诊断时1.5g/kg,48小时后1g/kg)超过6小时.在更长时间内输注标准剂量白蛋白的有效性，与减少剂量的白蛋白相比，应该在进一步的研究中进行评估。
背景：临床试验.gov标识符：NCT04273373。
