急性胰腺炎的积极或适度液体复苏。
Aggressive or Moderate Fluid Resuscitation in Acute Pancreatitis.
机构信息
From the Departments of Gastroenterology (E.M., L.G., A.V.-R.) and Clinical Pharmacology (P.Z.), Dr. Balmis General University Hospital, ISABIAL (Instituto de Investigación Sanitaria y Biomédica de Alicante), Alicante, the Department of Clinical Medicine, Faculty of Medicine, Miguel Hernández University, Elche (E.M.), the Department of Gastroenterology and Hepatology, Hospital Universitario Ramón y Cajal, Instituto Ramón y Cajal de Investigación Sanitaria, Universidad de Alcalá (A.G.G.P., M.Á.R.-G., J.D.-O.), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (P.Z., F.C.-S.), and the Gastroenterology Unit, Hospital Universitario de La Princesa, Instituto de Investigación Sanitaria Princesa (F.C.-S.), Madrid, the Gastroenterology and Digestive Endoscopy Unit, Corporació Sanitària Parc Taulí, Sabadell (A.L.-A., L.P.L.), the Department of Gastroenterology, Hospital Clínico Universitario de Valencia, Valencia (P.N., A.M.S.-P.), the Department of Gastroenterology and Hepatology, Marqués de Valdecilla University Hospital, Santander (C.S.-M., M.C.), the Department of Gastroenterology, Hospital Dr. Negrín, Las Palmas (I.F.-C.), the Department of Gastroenterology, Miguel Servet University Hospital and Health Research Institute of Aragón, Zaragoza (D.C.D.), the Department of Gastroenterology, Central de Asturias University Hospital, Instituto de Investigación Sanitaria del Principado de Asturias, Oviedo (E.L.-B.), the Department of Gastroenterology, Lucus Augusti University Hospital, Lugo (E.M.-M.), the Department of Gastroenterology, Puerta del Mar University Hospital, Cadiz (L.M.C.-M.), and the Department of Gastroenterology, University Hospital of Navarre, Pamplona (V.U., M.G., F.B.) - all in Spain; the Division of Gastroenterology, University of Southern California, Los Angeles (J.L.B.); the Division of Epidemiology and Biostatistics, IRCSS European Institute of Oncology, Milan (P.M.); the General Surgery Unit, Department of Diseases of the Digestive Tract, Regional Hospital of High Specialty of Bajío, Leon, Mexico (E.E.L.-H., A.J.R.C.M.); and the Department of Gastroenterology, Surat Institute of Digestive Sciences Hospital and Research Center, Surat, India (R.M., R.T.).
出版信息
N Engl J Med. 2022 Sep 15;387(11):989-1000. doi: 10.1056/NEJMoa2202884.
BACKGROUND
Early aggressive hydration is widely recommended for the management of acute pancreatitis, but evidence for this practice is limited.
METHODS
At 18 centers, we randomly assigned patients who presented with acute pancreatitis to receive goal-directed aggressive or moderate resuscitation with lactated Ringer's solution. Aggressive fluid resuscitation consisted of a bolus of 20 ml per kilogram of body weight, followed by 3 ml per kilogram per hour. Moderate fluid resuscitation consisted of a bolus of 10 ml per kilogram in patients with hypovolemia or no bolus in patients with normovolemia, followed by 1.5 ml per kilogram per hour in all patients in this group. Patients were assessed at 12, 24, 48, and 72 hours, and fluid resuscitation was adjusted according to the patient's clinical status. The primary outcome was the development of moderately severe or severe pancreatitis during the hospitalization. The main safety outcome was fluid overload. The planned sample size was 744, with a first planned interim analysis after the enrollment of 248 patients.
RESULTS
A total of 249 patients were included in the interim analysis. The trial was halted owing to between-group differences in the safety outcomes without a significant difference in the incidence of moderately severe or severe pancreatitis (22.1% in the aggressive-resuscitation group and 17.3% in the moderate-resuscitation group; adjusted relative risk, 1.30; 95% confidence interval [CI], 0.78 to 2.18; P = 0.32). Fluid overload developed in 20.5% of the patients who received aggressive resuscitation and in 6.3% of those who received moderate resuscitation (adjusted relative risk, 2.85; 95% CI, 1.36 to 5.94, P = 0.004). The median duration of hospitalization was 6 days (interquartile range, 4 to 8) in the aggressive-resuscitation group and 5 days (interquartile range, 3 to 7) in the moderate-resuscitation group.
CONCLUSIONS
In this randomized trial involving patients with acute pancreatitis, early aggressive fluid resuscitation resulted in a higher incidence of fluid overload without improvement in clinical outcomes. (Funded by Instituto de Salud Carlos III and others; WATERFALL ClinicalTrials.gov number, NCT04381169.).
背景
急性胰腺炎的治疗广泛推荐早期积极补液，但该治疗方法的证据有限。
方法
在 18 个中心，我们将出现急性胰腺炎的患者随机分配接受目标导向的积极或适度复苏治疗，使用乳酸林格氏液。积极补液包括体重 20ml/kg 的推注，随后 3ml/kg/h。中度补液在低血容量患者中包括体重 10ml/kg 的推注，在血容量正常患者中不推注，随后所有患者均为 1.5ml/kg/h。患者在 12、24、48 和 72 小时进行评估，并根据患者的临床状况调整液体复苏。主要结局是住院期间发生中度或重度胰腺炎。主要安全性结局是液体超负荷。计划样本量为 744 例，在入组 248 例后进行首次计划中期分析。
结果
共有 249 例患者纳入中期分析。由于组间安全性结局的差异而停止试验，而中度或重度胰腺炎的发生率没有显著差异（积极复苏组为 22.1%，中度复苏组为 17.3%；调整后的相对风险为 1.30；95%置信区间 [CI]，0.78 至 2.18；P=0.32）。接受积极复苏的患者中有 20.5%发生液体超负荷，接受适度复苏的患者中有 6.3%发生液体超负荷（调整后的相对风险，2.85；95%CI，1.36 至 5.94，P=0.004）。积极复苏组的中位住院时间为 6 天（四分位间距，4 至 8），适度复苏组为 5 天（四分位间距，3 至 7）。
结论
在这项涉及急性胰腺炎患者的随机试验中，早期积极补液导致液体超负荷的发生率增加，而临床结局没有改善。（由西班牙卡洛斯三世健康研究所和其他机构资助；WATERFALL ClinicalTrials.gov 编号，NCT04381169）。
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