Schreiber Martin A, Meier Eric N, Tisherman Samuel A, Kerby Jeffrey D, Newgard Craig D, Brasel Karen, Egan Debra, Witham William, Williams Carolyn, Daya Mohamud, Beeson Jeff, McCully Belinda H, Wheeler Stephen, Kannas Delores, May Susanne, McKnight Barbara, Hoyt David B
From the Department of Surgery, (M.A.S., B.H.M.), and Emergency Medicine, (C.D.N., MD.), Oregon Health & Science University, Portland, Oregon; Department of Biostatistics (E.N.M., S.M., B.M.), and Clinical Trial Center (D.K.), University of Washington, Seattle, Washington; Department of Surgery (S.A.T.), University of Maryland, Baltimore; and National Heart, Lung, and Blood Institute (D.E.), National Institutes of Health, Bethesda, Maryland; Department of Surgery (J.D.K., C.W.), University of Alabama at Birmingham, Birmingham, Alabama; Department of Surgery (K.B.), Medical College of Wisconsin, Milwaukee, Wisconsin; Trauma Surgery (W.W.), Texas Health Harris Methodist Hospital; and MedStar EMS, (J.B.), Fort Worth, Texas; American College of Surgeons (D.B.H.), Chicago, Illinois; and British Columbia Emergency Health Services (S.W.), Victoria, British Columbia, Canada.
J Trauma Acute Care Surg. 2015 Apr;78(4):687-95; discussion 695-7. doi: 10.1097/TA.0000000000000600.
Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients.
Patients were enrolled and randomized in the out-of-hospital setting. Nineteen emergency medical services (EMS) systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) of 90 mm Hg or lower. CR patients received 250 mL of fluid if they had no radial pulse or an SBP lower than 70 mm Hg and additional 250-mL boluses to maintain a radial pulse or an SBP of 70 mm Hg or greater. The SR group patients received 2 L initially and additional fluid as needed to maintain an SBP of 110 mm Hg or greater. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival.
A total of 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. The mean (SD) crystalloid volume administered during the study period was 1.0 L (1.5) in the CR group and 2.0 L (1.4) in the SR group, a difference of 1.0 L (95% confidence interval [CI], 0.6-1.4). Intensive care unit-free days, ventilator-free days, renal injury, and renal failure did not differ between the groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio, 0.39; 95% CI, 0.12-1.26). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted odds ratio of 0.17 (0.03-0.92). There was no difference among patients with penetrating trauma (9% vs. 9%; adjusted odds ratio, 1.93; 95% CI, 0.19-19.17).
CR is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted.
Therapeutic study, level I.
低血压创伤患者的最佳复苏方案尚未明确。本试验旨在评估控制性复苏（CR）与标准复苏（SR）用于低血压创伤患者的可行性和安全性。
患者在院外环境中入组并随机分组。复苏结局联盟的19个紧急医疗服务（EMS）系统参与其中。符合条件的患者院外收缩压（SBP）为90mmHg或更低。CR组患者若没有桡动脉搏动或SBP低于70mmHg，则给予250mL液体，随后根据需要追加250mL推注以维持桡动脉搏动或SBP在70mmHg或更高。SR组患者最初给予2L液体，并根据需要补充额外液体以维持SBP在110mmHg或更高。晶体液方案持续至出血得到控制或入院后2小时。
共有192例患者被随机分组（97例CR组和95例SR组）。CR组和SR组在基线时相似。研究期间CR组给予的晶体液平均（标准差）量为1.0L（1.5），SR组为2.0L（1.4），相差1.0L（95%置信区间[CI]，0.6 - 1.4）。两组在无重症监护病房天数、无呼吸机天数、肾损伤和肾衰竭方面无差异。入院24小时后，CR组有5例死亡（5%），SR组有14例（15%）（调整后的优势比为0.39；95%CI，0.12 - 1.26）。在钝性创伤患者中，24小时死亡率CR组为3%，SR组为18%，调整后的优势比为0.17（0.03 - 0.92）。穿透性创伤患者中无差异（9%对9%；调整后的优势比为1.93；95%CI，0.19 - 19.1）。
CR在院外和院内环境中均可实现，且可能在钝性创伤中提供早期生存优势。有必要进行一项大规模的III期试验来研究其对生存和其他临床结局的影响。
治疗性研究，I级。
