ICU 脓毒性休克患者的静脉液体限制。

Restriction of Intravenous Fluid in ICU Patients with Septic Shock.

机构信息

From Copenhagen University Hospital-Rigshospitalet (T.S.M., P.B.H., P. Sivapalan, M.H.M., M-B.N.K., C.O.-S., B.A.B., M.W.-O., J.O.W., L.Q., B.W., A.B.J., C.J.S.H., N.M., T.S.J., A.P.), the Copenhagen Trial Unit, Center for Clinical Intervention Research (J.W., J.E.), the Section of Biostatistics, University of Copenhagen (T.L.), Copenhagen University Hospital-Bispebjerg and Frederiksberg (S.K.L.H.), Copenhagen, Zealand University Hospital, Køge (L.N., N.C.A.-R., J.V.J., N.A.J., L.M.P., L.S.H.), Viborg Hospital, Viborg (C.G.S., S.K.P., K.K.K., T.S.S.), Randers Hospital, Randers (M.L.V., H.B.), Aalborg University Hospital, Aalborg University, Aalborg (B.S.R., S.R.A.), Zealand University Hospital, Roskilde (T.H., L.R.), Copenhagen University Hospital-North Zealand, Hillerød (M.H.B., M.S.-L.), Kolding Hospital, University of Southern Denmark, Kolding (A.C.B., C.F.E.), and Herning Hospital, Herning (M.L.R.) - all in Denmark; Oslo University Hospital, Oslo (J.H.L., T.N.A., S.Å.), Hospital Østfold Kalnes, Grålum (Y.K.M., F.F.F., H.S.), Stavanger University Hospital, Stavanger (P. Seidel, K.S.), and Hospital Innland Hamar, Hamar (B.J.) - all in Norway; Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset (M. Cronhjort, E.J.-A., J.C.), and Karolinska University Hospital, Huddinge (C.A.) - both in Sweden; Inselspital, Bern University Hospital, University of Bern, Bern (S.M.J., C.A.P.), and Basel University Hospital, Basel (M.S.) - both in Switzerland; IRCCS Humanitas Research Hospital, Humanitas University, Milan (M. Cecconi, M.G.); University Hospital Pilsen, Pilsen, Czech Republic (M.N., J.R., M.K.); Guy's and St. Thomas' Hospital (M.O.) and the Clinical Trials Unit, Intensive Care National Audit and Research Centre (D.W.G., K.M.R., P.R.M.) - both in London; University Hospital Brussels, Brussels (M.M.); and the University of Helsinki and Helsinki University Hospital, Helsinki (V.P.).

出版信息

N Engl J Med. 2022 Jun 30;386(26):2459-2470. doi: 10.1056/NEJMoa2202707. Epub 2022 Jun 17.

DOI:10.1056/NEJMoa2202707

PMID:35709019

Abstract

BACKGROUND

Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU).

METHODS

In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization.

RESULTS

We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups.

CONCLUSIONS

Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).

摘要

背景

静脉输液被推荐用于治疗感染性休克患者，但在重症监护病房（ICU）中，更高的液体量与患者的伤害有关。

方法

在这项国际、随机试验中，我们将 ICU 中接受过至少 1 升静脉输液的感染性休克患者分为接受限制液体或标准液体治疗的两组；如果休克发生在筛选前 12 小时内，则患者可以入组。主要结局是随机分组后 90 天内的任何原因死亡。

结果

我们纳入了 1554 名患者；770 名患者被分配到限制液体组，784 名患者被分配到标准液体组。主要结局数据可用于 1545 名患者（99.4%）。在 ICU 中，限制液体组接受的中位数静脉输液量为 1798 毫升（四分位距，500 至 4366）；标准液体组接受的中位数静脉输液量为 3811 毫升（四分位距，1861 至 6762）。90 天时，限制液体组 764 名患者中有 323 名（42.3%）死亡，标准液体组 781 名患者中有 329 名（42.1%）死亡（调整后的绝对差异，0.1 个百分点；95%置信区间[CI]，-4.7 至 4.9；P=0.96）。在 ICU 中，限制液体组 751 名患者中有 221 名（29.4%）至少发生过一次严重不良事件，标准液体组 772 名患者中有 238 名（30.8%）至少发生过一次严重不良事件（调整后的绝对差异，-1.7 个百分点；99%CI，-7.7 至 4.3）。随机分组后 90 天，两组患者无生命支持天数和出院天数相似。