Alasdair J Gray, Katherine Oatey, Julia Grahamslaw, Sîan Irvine, John Cafferkey, Titouan Kennel, John Norrie, Tim Walsh, Nazir Lone, Daniel Horner, Andy Appelboam, Peter Hall, Richard J E Skipworth, Derek Bell, Kevin Rooney, Manu Shankar-Hari, Alasdair R Corfield
{"title":"白蛋白与平衡晶体液在败血症早期复苏中的应用：开放式平行组随机可行性试验。ABC-败血症试验。","authors":"Alasdair J Gray, Katherine Oatey, Julia Grahamslaw, Sîan Irvine, John Cafferkey, Titouan Kennel, John Norrie, Tim Walsh, Nazir Lone, Daniel Horner, Andy Appelboam, Peter Hall, Richard J E Skipworth, Derek Bell, Kevin Rooney, Manu Shankar-Hari, Alasdair R Corfield","doi":"10.1097/CCM.0000000000006348","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital.</p><p><strong>Design: </strong>Multicenter, open, parallel-group randomized feasibility trial.</p><p><strong>Setting: </strong>Emergency departments (EDs) in 15 U.K. National Health Service (NHS) hospitals.</p><p><strong>Patients: </strong>Adult patients with sepsis and a National Early Warning Score 2 greater than or equal to five requiring IV fluids withing one hour of randomization.</p><p><strong>Interventions: </strong>IV fluid resuscitation with balanced crystalloid or 5% HAS for the first 6 hours following randomization.</p><p><strong>Measurements and main results: </strong>Primary feasibility outcomes were recruitment rate and 30-day mortality. We successfully recruited 301 participants over 12 months. Mean ( sd ) age was 69 years (± 16 yr), and 151 (50%) were male. From 1303 participants screened; 502 participants were potentially eligible and 300 randomized to receive trial intervention with greater than 95% of participants receiving the intervention. The median number of participants per site was 19 (range, 1-63). Thirty-day mortality was 17.9% ( n = 53). Thirty-one participants died (21.1%) within 30 days in the 5% HAS arm, compared with 22 participants (14.8%) in the crystalloid arm (adjusted odds ratio, 1.50; 95% CIs, 0.84-2.83).</p><p><strong>Conclusions: </strong>Our results suggest it is feasible to recruit critically ill patients to a fluid resuscitation trial in U.K. EDs using 5% HAS as a primary resuscitation fluid. There was lower mortality in the balanced crystalloid arm. Given these findings, a definitive trial is likely to be deliverable, but the point estimates suggest such a trial would be unlikely to demonstrate a significant benefit from using 5% HAS as a primary resuscitation fluid in sepsis.</p>","PeriodicalId":10765,"journal":{"name":"Critical Care Medicine","volume":" ","pages":"1520-1532"},"PeriodicalIF":7.7000,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial.\",\"authors\":\"Alasdair J Gray, Katherine Oatey, Julia Grahamslaw, Sîan Irvine, John Cafferkey, Titouan Kennel, John Norrie, Tim Walsh, Nazir Lone, Daniel Horner, Andy Appelboam, Peter Hall, Richard J E Skipworth, Derek Bell, Kevin Rooney, Manu Shankar-Hari, Alasdair R Corfield\",\"doi\":\"10.1097/CCM.0000000000006348\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objectives: </strong>International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital.</p><p><strong>Design: </strong>Multicenter, open, parallel-group randomized feasibility trial.</p><p><strong>Setting: </strong>Emergency departments (EDs) in 15 U.K. National Health Service (NHS) hospitals.</p><p><strong>Patients: </strong>Adult patients with sepsis and a National Early Warning Score 2 greater than or equal to five requiring IV fluids withing one hour of randomization.</p><p><strong>Interventions: </strong>IV fluid resuscitation with balanced crystalloid or 5% HAS for the first 6 hours following randomization.</p><p><strong>Measurements and main results: </strong>Primary feasibility outcomes were recruitment rate and 30-day mortality. We successfully recruited 301 participants over 12 months. Mean ( sd ) age was 69 years (± 16 yr), and 151 (50%) were male. From 1303 participants screened; 502 participants were potentially eligible and 300 randomized to receive trial intervention with greater than 95% of participants receiving the intervention. The median number of participants per site was 19 (range, 1-63). Thirty-day mortality was 17.9% ( n = 53). Thirty-one participants died (21.1%) within 30 days in the 5% HAS arm, compared with 22 participants (14.8%) in the crystalloid arm (adjusted odds ratio, 1.50; 95% CIs, 0.84-2.83).</p><p><strong>Conclusions: </strong>Our results suggest it is feasible to recruit critically ill patients to a fluid resuscitation trial in U.K. EDs using 5% HAS as a primary resuscitation fluid. There was lower mortality in the balanced crystalloid arm. Given these findings, a definitive trial is likely to be deliverable, but the point estimates suggest such a trial would be unlikely to demonstrate a significant benefit from using 5% HAS as a primary resuscitation fluid in sepsis.</p>\",\"PeriodicalId\":10765,\"journal\":{\"name\":\"Critical Care Medicine\",\"volume\":\" \",\"pages\":\"1520-1532\"},\"PeriodicalIF\":7.7000,\"publicationDate\":\"2024-10-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Critical Care Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/CCM.0000000000006348\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/6/24 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CRITICAL CARE MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Critical Care Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/CCM.0000000000006348","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/6/24 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CRITICAL CARE MEDICINE","Score":null,"Total":0}
Albumin Versus Balanced Crystalloid for the Early Resuscitation of Sepsis: An Open Parallel-Group Randomized Feasibility Trial- The ABC-Sepsis Trial.
Objectives: International guidelines recommend IV crystalloid as the primary fluid for sepsis resuscitation, with 5% human albumin solution (HAS) as the second line. However, it is unclear which fluid has superior clinical effectiveness. We conducted a trial to assess the feasibility of delivering a randomized controlled trial comparing balanced crystalloid against 5% HAS as sole early resuscitation fluid in patients with sepsis presenting to hospital.
Setting: Emergency departments (EDs) in 15 U.K. National Health Service (NHS) hospitals.
Patients: Adult patients with sepsis and a National Early Warning Score 2 greater than or equal to five requiring IV fluids withing one hour of randomization.
Interventions: IV fluid resuscitation with balanced crystalloid or 5% HAS for the first 6 hours following randomization.
Measurements and main results: Primary feasibility outcomes were recruitment rate and 30-day mortality. We successfully recruited 301 participants over 12 months. Mean ( sd ) age was 69 years (± 16 yr), and 151 (50%) were male. From 1303 participants screened; 502 participants were potentially eligible and 300 randomized to receive trial intervention with greater than 95% of participants receiving the intervention. The median number of participants per site was 19 (range, 1-63). Thirty-day mortality was 17.9% ( n = 53). Thirty-one participants died (21.1%) within 30 days in the 5% HAS arm, compared with 22 participants (14.8%) in the crystalloid arm (adjusted odds ratio, 1.50; 95% CIs, 0.84-2.83).
Conclusions: Our results suggest it is feasible to recruit critically ill patients to a fluid resuscitation trial in U.K. EDs using 5% HAS as a primary resuscitation fluid. There was lower mortality in the balanced crystalloid arm. Given these findings, a definitive trial is likely to be deliverable, but the point estimates suggest such a trial would be unlikely to demonstrate a significant benefit from using 5% HAS as a primary resuscitation fluid in sepsis.
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Critical Care Medicine is the premier peer-reviewed, scientific publication in critical care medicine. Directed to those specialists who treat patients in the ICU and CCU, including chest physicians, surgeons, pediatricians, pharmacists/pharmacologists, anesthesiologists, critical care nurses, and other healthcare professionals, Critical Care Medicine covers all aspects of acute and emergency care for the critically ill or injured patient.
Each issue presents critical care practitioners with clinical breakthroughs that lead to better patient care, the latest news on promising research, and advances in equipment and techniques.
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