早期肠内营养与肠外营养对需要机械通气和使用儿茶酚胺的患者死亡率的影响：一项随机对照试验（NUTRIREA-2）的研究方案
Impact of early enteral versus parenteral nutrition on mortality in patients requiring mechanical ventilation and catecholamines: study protocol for a randomized controlled trial (NUTRIREA-2).
作者信息
Brisard Laurent, Le Gouge Amélie, Lascarrou Jean-Baptiste, Dupont Hervé, Asfar Pierre, Sirodot Michel, Piton Gael, Bui Hoang-Nam, Gontier Olivier, Hssain Ali Ait, Gaudry Stéphane, Rigaud Jean-Philippe, Quenot Jean-Pierre, Maxime Virginie, Schwebel Carole, Thévenin Didier, Nseir Saad, Parmentier Erika, El Kalioubie Ahmed, Jourdain Mercé, Leray Véronique, Rolin Nathalie, Bellec Frédéric, Das Vincent, Ganster Frédérique, Guitton Christophe, Asehnoune Karim, Bretagnol Anne, Anguel Nadia, Mira Jean-Paul, Canet Emmanuel, Guidet Bertrand, Djibre Michel, Misset Benoit, Robert René, Martino Frédéric, Letocart Philippe, Silva Daniel, Darmon Michael, Botoc Vlad, Herbrecht Jean Etienne, Meziani Ferhat, Devaquet Jérôme, Mercier Emmanuelle, Richecoeur Jack, Martin Stéphanie, Gréau Emilie, Giraudeau Bruno, Reignier Jean
机构信息
UPRES EA-3826, Clinical and Experimental Therapies for Infections, University of Nantes, Nantes, France.
出版信息
Trials. 2014 Dec 23;15:507. doi: 10.1186/1745-6215-15-507.
BACKGROUND
Nutritional support is crucial to the management of patients receiving invasive mechanical ventilation (IMV) and the most commonly prescribed treatment in intensive care units (ICUs). International guidelines consistently indicate that enteral nutrition (EN) should be preferred over parenteral nutrition (PN) whenever possible and started as early as possible. However, no adequately designed study has evaluated whether a specific nutritional modality is associated with decreased mortality. The primary goal of this trial is to assess the hypothesis that early first-line EN, as compared to early first-line PN, decreases day 28 all-cause mortality in patients receiving IMV and vasoactive drugs for shock.
METHODS/DESIGN: The NUTRIREA-2 study is a multicenter, open-label, parallel-group, randomized controlled trial comparing early PN versus early EN in critically ill patients requiring IMV for an expected duration of at least 48 hours, combined with vasoactive drugs, for shock. Patients will be allocated at random to first-line PN for at least 72 hours or to first-line EN. In both groups, nutritional support will be started within 24 hours after IMV initiation. Calorie targets will be 20 to 25 kcal/kg/day during the first week, then 25 to 30 kcal/kg/day thereafter. Patients receiving PN may be switched to EN after at least 72 hours in the event of shock resolution (no vasoactive drugs for 24 consecutive hours and arterial lactic acid level below 2 mmol/L). On day 7, all patients receiving PN and having no contraindications to EN will be switched to EN. In both groups, supplemental PN may be added to EN after day 7 in patients with persistent intolerance to EN and inadequate calorie intake. We plan to recruit 2,854 patients at 44 participating ICUs.
DISCUSSION
The NUTRIREA-2 study is the first large randomized controlled trial designed to assess the hypothesis that early EN improves survival compared to early PN in ICU patients. Enrollment started on 22 March 2013 and is expected to end in November 2015.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01802099 (registered 27 February 2013).
背景
营养支持对于接受有创机械通气（IMV）的患者的治疗至关重要，且是重症监护病房（ICU）中最常用的治疗方法。国际指南一致表明，只要有可能，肠内营养（EN）应优先于肠外营养（PN），并尽早开始。然而，尚无设计充分的研究评估特定的营养方式是否与死亡率降低相关。本试验的主要目的是评估以下假设：与早期一线PN相比，早期一线EN可降低接受IMV和血管活性药物治疗休克的患者第28天的全因死亡率。
方法/设计：NUTRIREA - 2研究是一项多中心、开放标签、平行组、随机对照试验，比较在预计至少需要48小时IMV且因休克联合使用血管活性药物的重症患者中早期PN与早期EN的效果。患者将被随机分配接受至少72小时的一线PN或一线EN。在两组中，营养支持将在IMV开始后24小时内开始营养支持。第一周的热量目标为20至25千卡/千克/天，此后为25至30千卡/千克/天。接受PN的患者如果休克缓解（连续24小时无血管活性药物且动脉乳酸水平低于2毫摩尔/升），至少72小时后可改为EN。在第7天，所有接受PN且无EN禁忌证的患者将改为EN。在两组中，对于持续不耐受EN且热量摄入不足的患者，第7天后可在EN基础上加用补充PN。我们计划在44个参与的ICU招募2854名患者。
讨论
NUTRIREA - 2研究是第一项大型随机对照试验，旨在评估在ICU患者中早期EN与早期PN相比是否能提高生存率这一假设。入组于2013年3月22日开始，预计于2015年11月结束。
试验注册
ClinicalTrials.gov标识符：NCT01802099（2013年2月27日注册）。
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