Constantine J Karvellas, Ram Subramanian, Jody C Olson, Khurram Jamil
{"title":"特利加压素在入住重症监护室的肝肾综合征-急性肾损伤患者中的作用：CONFIRM 试验的一项子研究。","authors":"Constantine J Karvellas, Ram Subramanian, Jody C Olson, Khurram Jamil","doi":"10.1097/CCE.0000000000000890","DOIUrl":null,"url":null,"abstract":"<p><p>This study assessed the potential advantages of treating hepatorenal syndrome-acute kidney injury (HRS-AKI) with terlipressin versus placebo in the ICU setting.</p><p><strong>Design: </strong>Patients were randomly assigned in a 2:1 ratio to receive terlipressin or placebo for up to 14 days.</p><p><strong>Setting: </strong>A retrospective analysis of data from the phase III CONFIRM study.</p><p><strong>Participants: </strong>Adult patients with HRS-AKI admitted to the ICU.</p><p><strong>Main outcomes and measures: </strong>In this substudy, we evaluated outcomes of the ICU stay and the need for organ support, including renal replacement therapy (RRT).</p><p><strong>Results: </strong>Among 300 patients with HRS-AKI from the CONFIRM study, 45 were treated in the ICU (terlipressin, 31/199 [16%]; placebo, 14/101 [14%]). On ICU admission, baseline demographics were similar across treatment arms, including severity of liver dysfunction. Among patients alive at the end of the ICU stay, those randomized to terlipressin had a significantly shorter median length of ICU stay than placebo (4 vs 11 d; <i>p</i> < 0.001). Terlipressin-treated patients had a significantly larger improvement in renal function from baseline versus placebo (-0.7 vs +0.2 mg/dL; <i>p</i> = 0.001), including when accounting for the interaction between treatment and day-of-patient-admission to the ICU (-0.7 vs +0.9 mg/dL; <i>p</i> < 0.001). Cumulative requirement for RRT through day 90 was improved in the terlipressin arm versus placebo (10/31 [32%] vs 8/14 [57%]; <i>p</i> = 0.12), although not significantly. Of 13 patients who received a liver transplant, five out of five (100%) in the placebo arm needed RRT through day 90 versus five out of eight (63%) in the terlipressin arm.</p><p><strong>Conclusions: </strong>In this subanalysis of CONFIRM, patients admitted to the ICU with HRS-AKI who received terlipressin were more likely to achieve renal function improvement, based on serum creatinine changes by the end of treatment, and had significantly shorter lengths of ICU stay than patients randomized to the placebo arm.</p>","PeriodicalId":10759,"journal":{"name":"Critical Care Explorations","volume":"5 4","pages":"e0890"},"PeriodicalIF":0.0000,"publicationDate":"2023-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/90/72/cc9-5-e0890.PMC10060094.pdf","citationCount":"0","resultStr":"{\"title\":\"Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial.\",\"authors\":\"Constantine J Karvellas, Ram Subramanian, Jody C Olson, Khurram Jamil\",\"doi\":\"10.1097/CCE.0000000000000890\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>This study assessed the potential advantages of treating hepatorenal syndrome-acute kidney injury (HRS-AKI) with terlipressin versus placebo in the ICU setting.</p><p><strong>Design: </strong>Patients were randomly assigned in a 2:1 ratio to receive terlipressin or placebo for up to 14 days.</p><p><strong>Setting: </strong>A retrospective analysis of data from the phase III CONFIRM study.</p><p><strong>Participants: </strong>Adult patients with HRS-AKI admitted to the ICU.</p><p><strong>Main outcomes and measures: </strong>In this substudy, we evaluated outcomes of the ICU stay and the need for organ support, including renal replacement therapy (RRT).</p><p><strong>Results: </strong>Among 300 patients with HRS-AKI from the CONFIRM study, 45 were treated in the ICU (terlipressin, 31/199 [16%]; placebo, 14/101 [14%]). On ICU admission, baseline demographics were similar across treatment arms, including severity of liver dysfunction. Among patients alive at the end of the ICU stay, those randomized to terlipressin had a significantly shorter median length of ICU stay than placebo (4 vs 11 d; <i>p</i> < 0.001). Terlipressin-treated patients had a significantly larger improvement in renal function from baseline versus placebo (-0.7 vs +0.2 mg/dL; <i>p</i> = 0.001), including when accounting for the interaction between treatment and day-of-patient-admission to the ICU (-0.7 vs +0.9 mg/dL; <i>p</i> < 0.001). Cumulative requirement for RRT through day 90 was improved in the terlipressin arm versus placebo (10/31 [32%] vs 8/14 [57%]; <i>p</i> = 0.12), although not significantly. 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引用次数: 0
摘要
本研究评估了在重症监护室环境中使用特利加压素治疗肝肾综合征-急性肾损伤（HRS-AKI）与安慰剂相比的潜在优势：设计：按2:1的比例随机分配患者接受特利加压素或安慰剂治疗长达14天：对III期CONFIRM研究数据的回顾性分析：入住重症监护室的HRS-AKI成人患者：在这项子研究中，我们评估了重症监护室住院期间的结果和器官支持需求，包括肾脏替代疗法（RRT）：在CONFIRM研究的300例HRS-AKI患者中，有45例在重症监护室接受了治疗（特利加压素，31/199 [16%]；安慰剂，14/101 [14%]）。在重症监护室入院时，各治疗组的基线人口统计学特征相似，包括肝功能异常的严重程度。在重症监护室住院结束时仍存活的患者中，随机接受特利加压素治疗的患者的重症监护室住院时间中位数明显短于安慰剂（4 d vs 11 d; p < 0.001）。与安慰剂相比，特利加压素治疗患者的肾功能从基线改善的幅度明显更大（-0.7 vs +0.2 mg/dL；p = 0.001），包括考虑到治疗与患者入住重症监护室当天的交互作用（-0.7 vs +0.9 mg/dL；p < 0.001）。与安慰剂相比，特利加压素治疗组患者在第90天时的累计RRT需求有所改善（10/31 [32%] vs 8/14 [57%]；p = 0.12），但并不显著。在13名接受肝移植的患者中，安慰剂组5人（100%）在第90天需要接受RRT治疗，而特利加压素组8人中有5人（63%）需要接受RRT治疗：结论：在 CONFIRM 的这项子分析中，根据治疗结束时血清肌酐的变化，接受特利加压素治疗的 HRS-AKI 重症监护病房患者更有可能获得肾功能改善，而且重症监护病房的住院时间明显短于随机接受安慰剂治疗的患者。
Role of Terlipressin in Patients With Hepatorenal Syndrome-Acute Kidney Injury Admitted to the ICU: A Substudy of the CONFIRM Trial.
This study assessed the potential advantages of treating hepatorenal syndrome-acute kidney injury (HRS-AKI) with terlipressin versus placebo in the ICU setting.
Design: Patients were randomly assigned in a 2:1 ratio to receive terlipressin or placebo for up to 14 days.
Setting: A retrospective analysis of data from the phase III CONFIRM study.
Participants: Adult patients with HRS-AKI admitted to the ICU.
Main outcomes and measures: In this substudy, we evaluated outcomes of the ICU stay and the need for organ support, including renal replacement therapy (RRT).
Results: Among 300 patients with HRS-AKI from the CONFIRM study, 45 were treated in the ICU (terlipressin, 31/199 [16%]; placebo, 14/101 [14%]). On ICU admission, baseline demographics were similar across treatment arms, including severity of liver dysfunction. Among patients alive at the end of the ICU stay, those randomized to terlipressin had a significantly shorter median length of ICU stay than placebo (4 vs 11 d; p < 0.001). Terlipressin-treated patients had a significantly larger improvement in renal function from baseline versus placebo (-0.7 vs +0.2 mg/dL; p = 0.001), including when accounting for the interaction between treatment and day-of-patient-admission to the ICU (-0.7 vs +0.9 mg/dL; p < 0.001). Cumulative requirement for RRT through day 90 was improved in the terlipressin arm versus placebo (10/31 [32%] vs 8/14 [57%]; p = 0.12), although not significantly. Of 13 patients who received a liver transplant, five out of five (100%) in the placebo arm needed RRT through day 90 versus five out of eight (63%) in the terlipressin arm.
Conclusions: In this subanalysis of CONFIRM, patients admitted to the ICU with HRS-AKI who received terlipressin were more likely to achieve renal function improvement, based on serum creatinine changes by the end of treatment, and had significantly shorter lengths of ICU stay than patients randomized to the placebo arm.
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