{"id":29813,"date":"2025-12-27T04:50:00","date_gmt":"2025-12-26T20:50:00","guid":{"rendered":"https:\/\/csccm.org.cn\/?p=29813"},"modified":"2025-12-27T06:44:09","modified_gmt":"2025-12-26T22:44:09","slug":"lancet%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e9%87%87%e5%8f%96%e9%a2%84%e9%98%b2%e6%8e%aa%e6%96%bd%e5%87%8f%e5%b0%91%e5%a4%a7%e6%89%8b%e6%9c%af%e5%90%8e%e7%9a%84%e4%b8%ad%e9%87%8d%e5%ba%a6","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=29813","title":{"rendered":"[Lancet\u53d1\u8868\u8bba\u6587]\uff1a\u91c7\u53d6\u9884\u9632\u63aa\u65bd\u51cf\u5c11\u5927\u624b\u672f\u540e\u7684\u4e2d\u91cd\u5ea6\u6025\u6027\u80be\u635f\u4f24"},"content":{"rendered":"\n

Articles<\/p>\n\n\n\n

A preventive care strategy to reduce moderate or severe acute kidney injury after major surgery (BigpAK-2); a multinational, randomised clinical trial<\/h1>\n\n\n\n

Alexander\u00a0Zarboci,\u00a0Marlies\u00a0Ostermann,\u00a0Lui\u00a0Forni, et al<\/h3>\n\n\n\n

Lancet 2025; 406: 2787-2791<\/h3>\n\n\n\n

https:\/\/doi.org\/10.1016\/S0140-6736(25)01717-9<\/h3>\n\n\n\n

Summary<\/h2>\n\n\n\n

Background<\/h3>\n\n\n\n

Acute kidney injury (AKI) is a common and important complication of major surgery, yet recommended preventive care is rarely administered. We used urinary biomarkers to identify patients at high risk of AKI and implemented a preventive care strategy to reduce AKI within 72 h after major surgery.<\/p>\n\n\n\n

Methods<\/h3>\n\n\n\n

BigpAK-2 was a multicentre randomised clinical trial done in 34 hospitals in Europe. Patients (aged \u226518 years) undergoing major surgery at high risk for AKI identified by predefined clinical risk factors and tubular stress biomarkers were randomly assigned to usual care or a preventive care strategy as per recommendations by the Kidney Disease Improving Global Outcome guidelines: advanced hemodynamic monitoring, optimisation of volume status and haemodynamics, avoidance of nephrotoxic drugs and radiocontrast agents, and prevention of hyperglycaemia. The primary outcome was the occurrence of moderate or severe AKI within 72 h after surgery, assessed in the intention-to-treat population. Safety was assessed by comparing rates of adverse events between groups. This trial is registered with ClinicalTrials.gov<\/a>, NCT04647396<\/a>.<\/p>\n\n\n\n

Findings<\/h3>\n\n\n\n

From Nov 25, 2020, to June 21, 2024, 7873 patients were screened and 1180 (15\u00b70%) were randomly assigned (589 [49\u00b79%] to the intervention group and 591 [50\u00b71%] to the control group). Among the 1176 patients available for the primary endpoint analysis, moderate or severe AKI occurred in 84 (14\u00b74%) patients in the intervention group and in 131 (22\u00b73%) patients in the control group (odds ratio 0\u00b757 [95% CI 0\u00b740\u20130\u00b779; p=0\u00b70002; number needed to treat 12 [7\u201333]). There were no differences in adverse events. The most common adverse events were atrial fibrillation (50 [8\u00b78%] in the intervention group\u00a0vs<\/em>\u00a056 (9\u00b77%) in the control group), hemodynamically relevant arrhythmias (41 [7\u00b72%] in the intervention group\u00a0vs<\/em>\u00a050 [8\u00b76%] in the control group), significant bleeding or haemorrhage (34 [6\u00b70%] in the intervention group\u00a0vs<\/em>\u00a031 [5\u00b73%] in the control group), and unplanned return to the operating room (29 [5\u00b71%] in the intervention\u00a0vs<\/em>\u00a038 [6\u00b75%] in the control group).<\/p>\n\n\n\n

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Table 1. Baseline and ICU admission data<\/p>\n\n\n\n

Empty Cell<\/td>Empty Cell<\/td>Intervention (n=589)<\/strong><\/th>Control (n=591)<\/strong><\/th><\/tr><\/thead>
Patient demographics<\/strong><\/td><\/tr>
Age, years<\/td>72\u00b70 (63\u00b70\u201378\u00b70)<\/td>71\u00b70 (63\u00b70\u201377\u00b70)<\/td><\/tr>
Sex<\/td><\/tr>
<\/td>Male<\/td>390 (66\u00b72%)<\/td>394 (66\u00b77%)<\/td><\/tr>
<\/td>Female sex<\/td>199 (33\u00b78%)<\/td>197 (33\u00b77%)<\/td><\/tr>
Height, cm<\/td>172\u00b70 (164\u00b70\u2013178\u00b70)<\/td>172\u00b70 (165\u00b70\u2013179\u00b70)<\/td><\/tr>
Bodyweight, kg<\/td>79\u00b70 (66\u00b74\u201390\u00b70)<\/td>79\u00b70 (69\u00b70\u201392\u00b70)<\/td><\/tr>
BMI, kg\/m2<\/sup><\/td>26\u00b73 (23\u00b73\u201330\u00b71)<\/td>26\u00b74 (23\u00b77\u201330\u00b71)<\/td><\/tr>
Preoperative serum creatinine, mg\/dL<\/td>0\u00b790 (0\u00b773\u20131\u00b713)<\/td>0\u00b791 (0\u00b776\u20131\u00b713)<\/td><\/tr>
Comorbidities<\/strong><\/td><\/tr>
ASA score*<\/a><\/td><\/tr>
<\/td>1 (healthy)<\/td>1 (0\u00b72%)<\/td>8 (1\u00b76%)<\/td><\/tr>
<\/td>2 (mild or moderate illness)<\/td>107 (21\u00b74%)<\/td>106 (20\u00b77%)<\/td><\/tr>
<\/td>3 (severe general illness)<\/td>323 (64\u00b75%)<\/td>317 (61\u00b79%)<\/td><\/tr>
<\/td>4 (life-threatening general illness)<\/td>70 (14\u00b70%)<\/td>81 (15\u00b78%)<\/td><\/tr>
Hypertension<\/td>419 (73\u00b70%)<\/td>402 (70\u00b70%)<\/td><\/tr>
Congestive heart failure<\/td><\/tr>
<\/td>NYHA I<\/td>24 (5\u00b74%)<\/td>20 (4\u00b73%)<\/td><\/tr>
<\/td>NYHA II<\/td>62 (14\u00b71%)<\/td>51 (11\u00b70%)<\/td><\/tr>
<\/td>NYHA III<\/td>37 (8\u00b74%)<\/td>40 (8\u00b77%)<\/td><\/tr>
<\/td>NYHA VI<\/td>3 (0\u00b77%)<\/td>1 (0\u00b72%)<\/td><\/tr>
APACHE II score\u2020<\/sup><\/a><\/td>14 (10\u201321)<\/td>15 (10\u201321)<\/td><\/tr>
Peripheral vascular disease<\/td>80 (13\u00b79%)<\/td>79 (13\u00b76%)<\/td><\/tr>
Diabetes of any type<\/td><\/tr>
<\/td>Non-insulin dependent<\/td>105 (18\u00b73%)<\/td>91 (15\u00b76%)<\/td><\/tr>
<\/td>Insulin dependent<\/td>41 (7\u00b71%)<\/td>48 (8\u00b72%)<\/td><\/tr>
Previous stroke or transient ischemic attack<\/td>40 (7\u00b70%)<\/td>45 (7\u00b77%)<\/td><\/tr>
Chronic liver disease<\/td>52 (9\u00b70%)<\/td>52 (8\u00b79%)<\/td><\/tr>
Chronic kidney disease<\/td><\/tr>
<\/td>Stage 3a (eGFR 59\u201345 mL\/min per 1\u00b773 m2<\/sup>)<\/td>89 (15\u00b75%)<\/td>72 (12\u00b74%)<\/td><\/tr>
<\/td>Stage 3b (eGFR 44\u201330 mL\/min per 1\u00b773 m2<\/sup>)<\/td>44 (7\u00b76%)<\/td>47 (8\u00b71%)<\/td><\/tr>
Chronic obstructive pulmonary disease<\/td>63 (11\u00b70%)<\/td>75 (12\u00b79%)<\/td><\/tr>
Previous myocardial infarction<\/td>72 (12\u00b75%)<\/td>72 (12\u00b74%)<\/td><\/tr>
Cancer<\/td>222 (38\u00b76%)<\/td>226 (38\u00b78%)<\/td><\/tr>
Medication<\/strong><\/td><\/tr>
Beta-blockers<\/td>263 (45\u00b77%)<\/td>270 (46\u00b74%)<\/td><\/tr>
ACE inhibitors<\/td>156 (27\u00b72%)<\/td>147 (25\u00b72%)<\/td><\/tr>
ARBs<\/td>139 (24\u00b72%)<\/td>142 (24\u00b74%)<\/td><\/tr>
Diuretics<\/td>212 (37\u00b70%)<\/td>211 (36\u00b72%)<\/td><\/tr>
Statins<\/td>281 (49\u00b70%)<\/td>280 (48\u00b70%)<\/td><\/tr>
Anticoagulation<\/td>174 (30\u00b73%)<\/td>169 (29\u00b70%)<\/td><\/tr>
NSAIDs<\/td>25 (4\u00b74%)<\/td>36 (6\u00b72%)<\/td><\/tr><\/tbody><\/table>
Data are n (%) or median (IQR). Numbers and percentages are provided where they are not missing. It is therefore possible that the figures do not add up to the total number of the cohort. SI conversion factor: to convert creatinine to \u03bcmol\/L, multiply by 88\u00b74. ACE=angiotensin-converting enzyme. APACHE=Acute Physiology And Chronic Health Evaluation. ARB=angiotensin II receptor blocker. ASA=American Society of Anesthesiology. eGFR=estimated glomerular filtration rate. ICU=intensive care unit. NSAID=non-steroidal anti-inflammatory drug. NYHA=New York Heart Association Functional Classification.*
ASA classification are defined as: 3, a patient with severe systemic disease that limits physical activity; and 4, a patient with severe systemic disease that is a constant threat to life (patients with grade 1, 2 and 5 scores were not eligible for inclusion).\u2020
APACHE II is an ICU mortality prediction score with values ranging from 0 to 71. Higher values indicate higher probability of mortality (score 25\u201329: 55% mortality). The score is calculated on the basis of data collected within the first 24 h after ICU admission.<\/figcaption><\/figure>\n\n\n\n

Table 2. Surgical and clinical data up to randomisation<\/p>\n\n\n\n

Empty Cell<\/td>Empty Cell<\/td>Intervention (n=589)<\/strong><\/th>Control (n=591)<\/strong><\/th><\/tr><\/thead>
Surgical category<\/strong><\/td><\/tr>
Elective<\/td>513 (89\u00b72%)<\/td>531 (91\u00b72%)<\/td><\/tr>
Emergency<\/td>62 (10\u00b78%)<\/td>51 (8\u00b78%)<\/td><\/tr>
Surgical discipline<\/strong><\/td><\/tr>
General or abdominal<\/td>194 (33\u00b75%)<\/td>208 (35\u00b75%)<\/td><\/tr>
Cardiac<\/td>197 (34\u00b70%)<\/td>185 (31\u00b76%)<\/td><\/tr>
Vascular<\/td>87 (15\u00b70%)<\/td>93 (15\u00b79%)<\/td><\/tr>
Thoracic<\/td>25 (4\u00b73%)<\/td>27 (4\u00b76%)<\/td><\/tr>
Urological<\/td>25 (4\u00b73%)<\/td>25 (3\u00b74%)<\/td><\/tr>
Orthopaedic or trauma<\/td>10 (1\u00b77%)<\/td>13 (2\u00b72%)<\/td><\/tr>
Gynaecological<\/td>10 (1\u00b77%)<\/td>14 (2\u00b74%)<\/td><\/tr>
Other (eg, neurosurgery, plastics, or oral or maxillofacial)<\/td>31 (5\u00b74%)<\/td>26 (4\u00b74%)<\/td><\/tr>
Intraoperative clinical data, fluid, and vasopressor management<\/strong><\/td><\/tr>
Fluid administration, mL<\/td><\/tr>
<\/td>Crystalloids<\/td>2243 (1224\u20135012)<\/td>2366 (1316\u20135239)<\/td><\/tr>
<\/td>Colloids (hydroxyethyl starch, gelatin, or albumin)<\/td>500 (100\u20131000)<\/td>500 (200\u20131000)<\/td><\/tr>
Blood products, mL<\/td><\/tr>
<\/td>Red blood cell concentration<\/td>600 (350\u20131000)<\/td>680 (463\u20131200)<\/td><\/tr>
<\/td>Platelet concentratation<\/td>400 (250\u2013500)<\/td>400 (250\u2013600)<\/td><\/tr>
<\/td>Fresh frozen plasma<\/td>1000 (750\u20131450)<\/td>1200 (750\u20132000)<\/td><\/tr>
Fluid balance, mL<\/td><\/tr>
<\/td>Urine output<\/td>450 (250\u2013800)<\/td>500 (250\u20131000)<\/td><\/tr>
<\/td>Blood loss<\/td>200 (0\u2013600)<\/td>300 (0\u2013700)<\/td><\/tr>
<\/td>Total fluid balance<\/td>1920 (1002\u20133497)<\/td>1998 (1000\u20133500)<\/td><\/tr>
Vasopressors (cumulative intraoperative dose until ICU admission)<\/td><\/tr>
<\/td>Norepinephrine, \u03bcg<\/td>1720 (802\u20133705)<\/td>1590 (720\u20133000)<\/td><\/tr>
<\/td>Adrenaline, \u03bcg<\/td>491 (285\u20131320)<\/td>592 (204\u20131590)<\/td><\/tr>
<\/td>Vasopressin, IU<\/td>9\u00b78 (3\u00b70\u201316\u00b75)<\/td>4\u00b78 (3\u00b72\u201311\u00b77)<\/td><\/tr>
<\/td>Dobutamine, mg<\/td>27\u00b77 (16\u00b72\u201359\u00b70)<\/td>28\u00b72 (15\u00b73\u201347\u00b74)<\/td><\/tr>
Baseline TIMP-2 \u00d7 IGFBP7 (ng\/mL)2<\/sup>\/1000<\/td>0\u00b765 (0\u00b743\u20131\u00b720)<\/td>0\u00b766 (0\u00b744\u20131\u00b726)<\/td><\/tr><\/tbody><\/table>
Data are n (%) or median (IQR). Numbers and percentages are provided where they are not missing. It is therefore possible that the figures do not add up to the total number of the cohort. ICU=intensive care unit.<\/figcaption><\/figure>\n\n\n\n

Table 3. Primary and secondary outcomes<\/p>\n\n\n\n

Empty Cell<\/td>Empty Cell<\/td>Empty Cell<\/td>Intervention (n=589)<\/strong><\/th>Control (n=591)<\/strong><\/th>Effect estimate (95% CI)<\/strong><\/th>p value<\/strong><\/th><\/tr><\/thead>
Moderate or severe AKI within 72 h<\/td>84\/584 (14\u00b74)<\/td>131\/588 (22\u00b73)<\/td>OR 0\u00b757 (0\u00b740 to 0\u00b779)<\/td>0\u00b70002<\/td><\/tr>
Secondary outcomes: renal endpoints<\/td><\/tr>
<\/td>Any AKI within 72 h<\/td>213\/584 (36\u00b75%); 584 non-missing<\/td>240\/588 (40\u00b78%); 588 non-missing<\/td>OR 0\u00b778 (0\u00b760 to 1\u00b701)<\/td>..<\/td><\/tr>
<\/td><\/td>Stage 1<\/td>129\/213 (60\u00b76%); 584 non-missing<\/td>109\/240 (45\u00b74%); 588 non-missing<\/td>AD 15\u00b72 (6\u00b71 to 24\u00b72)<\/td>..<\/td><\/tr>
<\/td><\/td>Stage 2<\/td>50\/213 (23\u00b7%5); 584 non-missing<\/td>93\/240 (38\u00b78%); 588 non-missing<\/td>AD \u221215\u00b73 (\u221223\u00b77 to \u22126\u00b79)<\/td>..<\/td><\/tr>
<\/td><\/td>Stage 3<\/td>34\/213 (16\u00b70%); 584 non-missing<\/td>38\/240 (15\u00b78%); 588 non-missing<\/td>AD 0\u00b71 (\u22126\u00b76 to 6\u00b79)<\/td>..<\/td><\/tr>
<\/td>Duration of moderate or severe AKI<\/td><\/tr>
<\/td><\/td>Transient (\u226448 h)<\/td>50\/82 (61\u00b70%); 582 non-missing<\/td>71\/128 (55\u00b75%); 585 non-missing<\/td>AD 5\u00b75 (\u22128\u00b71 to 19\u00b71)<\/td>..<\/td><\/tr>
<\/td><\/td>Persistent (>48 h)<\/td>32\/82 (39\u00b70%); 582 non-missing<\/td>57\/128 (44\u00b75%); 585 non-missing<\/td>AD \u22125\u00b75 (\u221219\u00b71 to 8\u00b71)<\/td><\/td><\/tr>
Secondary outcomes: clinical endpoints<\/td><\/tr>
<\/td>Full KDIGO adherence<\/td>268 (46\u00b79%); 572 non-missing<\/td>29 (5\u00b70%); 577 non-missing<\/td>OR 11\u00b758 (7\u00b716 to 18\u00b773)<\/td>..<\/td><\/tr>
<\/td>Change in biomarker values during 12 h following initial measurement<\/td>\u22120\u00b724 (\u22120\u00b771 to 0\u00b710); 447 non-missing<\/td>\u22120\u00b726 (\u22120\u00b770 to 0\u00b709); 439 non-missing<\/td>AD 0\u00b702 (\u22120\u00b707 to 0\u00b711)<\/td>..<\/td><\/tr>
<\/td>RRT up to day 30<\/td>30 (5\u00b71%); 587 non-missing<\/td>34 (5\u00b78%); 589 non-missing<\/td>OR 0\u00b7881 (0\u00b7517 to 1\u00b7501)<\/td>..<\/td><\/tr>
<\/td>RRT up to day 90<\/td>30 (5\u00b71%); 587 non-missing<\/td>35 (5\u00b79%); 589 non-missing<\/td>OR 0\u00b7861 (0\u00b7509 to 1\u00b7456)<\/td>..<\/td><\/tr>
<\/td>Deaths until day 30<\/td>30 (5\u00b71%); 587 non-missing<\/td>27 (4\u00b76%); 589 non-missing<\/td>..<\/td>..<\/td><\/tr>
<\/td>Deaths until day 90<\/td>41 (7\u00b70%); 587 non-missing<\/td>41 (7\u00b70%); 589 non-missing<\/td>..<\/td>..<\/td><\/tr>
<\/td>Survival rate<\/td>0\u00b793 (0\u00b791 to 0\u00b795); 587 non-missing<\/td>0\u00b793 (0\u00b790 to 0\u00b795); 589 non-missing<\/td>HR 1\u00b7063 (0\u00b7692 to 1\u00b7634)<\/td>..<\/td><\/tr>
<\/td>Days without mechanical organ support until day 3<\/td>3 (3 to 3); 452 non-missing<\/td>3 (2 to 3); 437 non-missing<\/td>HL 0 (0 to 0)<\/td>..<\/td><\/tr>
<\/td>Days without vasopressors until day 3<\/td>2 (0 to 3); 587 non-missing<\/td>2 (0 to 3); 589 non-missing<\/td>HL 0 (0 to 0)<\/td>..<\/td><\/tr>
<\/td>ICU length of stay, days<\/td>2\u00b794 (1\u00b714 to 6\u00b793); 577 non-missing<\/td>2\u00b782 (1\u00b704 to 6\u00b713); 584 non-missing<\/td>HL \u22120\u00b708 (\u22120\u00b729 to 0\u00b706)<\/td>..<\/td><\/tr>
<\/td>Hospital length of stay, days<\/td>15\u00b767 (9\u00b765 to 30\u00b750); 577 non-missing<\/td>15\u00b770 (9\u00b770 to 28\u00b771); 584 non-missing<\/td>HL \u22120\u00b701 (\u22121\u00b711 to 1\u00b708)<\/td>..<\/td><\/tr>
<\/td>Renal recovery at day 90<\/td>206 (35\u00b71%); 587 non-missing<\/td>195 (33\u00b71%); 589 non-missing<\/td>OR 1\u00b7107 (0\u00b7852 to 1\u00b7438)<\/td>..<\/td><\/tr>
<\/td>Major adverse kidney event until day 30<\/td>51 (9\u00b70%); 565 non-missing<\/td>50 (8\u00b78%); 567 non-missing<\/td>OR 1\u00b7009 (0\u00b7658 to 1\u00b7545)<\/td>..<\/td><\/tr>
<\/td>Major adverse kidney event until day 90<\/td>61 (11\u00b70%); 555 non-missing<\/td>60 (10\u00b76%); 564 non-missing<\/td>OR 1\u00b7026 (0\u00b7692 to 1\u00b7522)<\/td>..<\/td><\/tr><\/tbody><\/table>
Data are n (%) or median (IQR), unless otherwise indicated. Numbers and percentages are provided where they are not missing; it is therefore possible that the figures do not add up to the total number of the cohort. AD=absolute difference. HL=Hodges\u2013Lehman estimator. HR=hazard ratio. ICU=intensive care unit. OR=odds ratio.<\/figcaption><\/figure>\n\n\n\n

Interpretation<\/h3>\n\n\n\n

Among adults at high risk for AKI undergoing major surgery, a preventive care strategy consisting of supportive measures and avoidance of nephrotoxins significantly reduced the occurrence of moderate or severe AKI without increasing adverse events.<\/p>\n\n\n\n

Funding<\/h3>\n\n\n\n

BioM\u00e9rieux.<\/p>\n","protected":false},"excerpt":{"rendered":"

Articles A preventive care strategy to reduce moderate […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/29813"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=29813"}],"version-history":[{"count":1,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/29813\/revisions"}],"predecessor-version":[{"id":29814,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/29813\/revisions\/29814"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=29813"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=29813"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=29813"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}