Supplemental Parenteral Nutrition to Reduce Death in Malnourished ICU Patients

补充肠外营养可减少营养不良 ICU 患者的死亡

基本信息

  • 批准号:
    8465899
  • 负责人:
  • 金额:
    $ 18.04万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2012
  • 资助国家:
    美国
  • 起止时间:
    2012-05-03 至 2015-04-30
  • 项目状态:
    已结题

项目摘要

DESCRIPTION (provided by applicant): This application addresses the National Heart, Lung, and Blood Institutes Clinical Trial Pilot Studies (R34). Background: The optimal amount of calories and protein a critically ill patient should receive to reduce morbidity and mortality is unclear and remains controversial. Review of current practice in ICU patients indicates the actual amounts of enteral energy and protein delivered by standard hospital nutrition protocols is well below what is prescribed. U.S. ICU's were the least successful worldwide in delivering prescribed calories and protein. Despite aggressive, repeated efforts with guidelines and quality improvement initiatives over past years the amount of calories delivered via the enteral route has not significantly improved. Thus, if we are to successfully improve provision of energy and protein to patients at-risk of death from insufficient caloric delivery, we will have to supply calories via the intravenous parenteral nutrition (PN) route. Various national guidelines make different recommendations on the role of PN in the ICU, international audits show considerable practice variations, and existing clinical trial data, albeit it weak and outdated, are split on the use of PN in the early phase of critical illness (with some showing a mortality benefit and some showing no mortality benefit or possible increased infection risk from PN). However, a large recent observational research shows the amount of energy and protein received during the early stages of ICU admission impacts patient mortality, independent of route of delivery. This data from an international multicenter observational study of 2772 ICU patients in 165 ICUs who were expected to require mechanical ventilation for > 72 h found a significant inverse linear relationship between the odds of mortalit and total daily calories received. The key finding is that increased amounts of calories significantly reduced mortality for the patients with a BMI<25 and a BMI>35 with no benefit of increased calorie intake for patients in the BMI 25-<35 group. Feeding an additional 1000 kcals almost halved the odds of 60-day mortality in patients with a BMI <25 or >35. Similar results were observed for feeding an additional 30 grams of protein per day. Thus, Our Hypothesis is increased calorie and protein delivery to underweight and overweight critically ill patients with ARF (Body Mass Index [BMI] <25 or >35) will result in improved 60 day survival compared to usual care Our Specific Aim is to conduct a multinational, multicenter double-blind randomized controlled trial of EN plus supplemental PN vs EN and a parenteral placebo solution (standard care) in lean and obese critically ill patients with acute respiratory failure (ARF). Such a trial powered to show differences in 60-day mortality would require approximately 2000 patients. However, as we are uncertain of the feasibility and safety of conducting such a large study, thus in this application we propose pilot study of 160 patients in 6 centers will be conducted initially The main aim of the pilot study is to confirm we can safely achieve a clinically significant difference in caloric intake between the two study groups, without any increased risk from the supplemental PN. Study Design: The pilot study is a 6-center, double-blinded, placebo-controlled, randomized trial. Patients will be randomized to either: EN plus placebo PN solution or EN plus PN. Study Population: 160 critically ill patients with ARF (defined as expected to require mechanical ventilation > 72 h) to be initiated on EN within 48 h of ICU admission who have a pre-illness BMI < 25 and >35. Study Intervention: Eligible patients will be randomized within 48 h of ICU admission. In both groups, EN will be initiated and progressed to target dose according to a standard feeding protocol with a standard 1.2 kcal/ml formula. The intervention group will receive additional protein/energy via PN. This parenteral solution contains 1.2 cal/ml, similar to the EN solution. A placebo solution containing 1/2 normal saline will be used to maintain blinding in the control group. The relative amount of PN and EN will be monitored and adjusted daily to ensure that the patient receives 100% of prescribed calories daily. The supplemental PN solution or placebo PN will continue for 7 days. At the end of this study period, the study intervention will be stopped and clinicians can prescribe nutrition (PN or EN) as clinically indicated in both groups. Outcomes: This proposed pilot study will measure all clinical outcomes (e.g. mortality). The primary aim of this pilot study is to achieve a 30% difference in caloric and protein delivery difference (600-100 kcal/d and 20-30 g protein/d) between the control and intervention groups. Study patients will also be followed prospectively while in the ICU, to document compliance with the study intervention, maintenance of blinding, and adverse events. This will enable us to assess the feasibility of conducting the larger, definitive trial. Te results of this full-scale definitive study will serve to answer fundamental questions with regards to impact of amount of energy and protein delivered to nutritionally at-risk ICU patients and will for the first time in many years inform current practice on the use PN in the ICU.
描述(由申请人提供): 本申请涉及国家心脏、肺和血液研究所临床试验初步研究(R34)。背景资料:危重患者应接受的最佳卡路里和蛋白质量以降低发病率和死亡率尚不清楚,仍存在争议。对ICU患者当前实践的回顾表明,通过标准医院营养方案输送的肠内能量和蛋白质的实际量远低于处方量。美国ICU在提供规定的卡路里和蛋白质方面是世界上最不成功的。尽管在过去几年中积极地反复努力制定指南和质量改进计划,但通过肠内途径输送的卡路里量并未显著改善。因此,如果我们要成功地改善因热量输送不足而有死亡风险的患者的能量和蛋白质供应,我们将不得不通过静脉注射肠外营养(PN)途径提供热量。不同的国家指南对PN在ICU中的作用提出了不同的建议,国际审计显示了相当大的实践差异,现有的临床试验数据,尽管其薄弱和过时,但在危重病早期使用PN方面存在分歧(有些显示死亡率获益,有些显示没有死亡率获益或PN可能增加感染风险)。然而,最近的一项大型观察性研究表明,在ICU入院的早期阶段接受的能量和蛋白质的量会影响患者的死亡率,与分娩途径无关。该数据来自一项国际多中心观察性研究,该研究纳入了165个ICU中的2772名预计需要机械通气> 72 h的ICU患者,发现死亡率与每日总热量之间存在显著的负线性关系。关键的发现是,增加热量显著降低了BMI 35患者的死亡率<25 and a BMI>,而BMI 25-&lt;35组患者的卡路里摄入量增加没有任何好处。在BMI 35的患者中,额外喂养1000千卡几乎使60天死亡率减半<25 or >。每天额外喂饲30克蛋白质也观察到类似的结果。因此,我们的假设是,与常规治疗相比,体重不足和超重的ARF危重患者(体重指数[BMI] 35)的热量和蛋白质输送增加<25 or >将导致60天生存率提高。我们的具体目标是在患有急性呼吸衰竭(ARF)的瘦型和肥胖型危重患者中进行一项多国、多中心双盲随机对照试验,比较EN+补充PN与EN+胃肠外安慰剂溶液(标准治疗)。这样一项有能力显示60天死亡率差异的试验将需要大约2000名患者。然而,由于我们不确定进行此类大型研究的可行性和安全性,因此在本申请中,我们建议最初在6个中心进行160例患者的初步研究。初步研究的主要目的是证实我们可以安全地实现两个研究组之间热量摄入的临床显著差异,而不会增加补充PN的任何风险。研究设计:初步研究是一项6中心、双盲、安慰剂对照、随机试验。患者将随机分配至EN+安慰剂PN溶液组或EN + PN组。研究人群:160例ARF危重患者(定义为预计需要机械通气&gt; 72小时)在入住ICU后48小时内开始EN治疗,患者患病前BMI < 25 and >35。研究干预:合格患者将在ICU入院后48小时内随机分配。在两组中,EN将根据标准喂养方案使用标准1.2 kcal/ml配方开始并进展至目标剂量。干预组将通过PN接受额外的蛋白质/能量。该胃肠外溶液含有1.2 cal/ml,与EN溶液相似。对照组将使用含1/2生理盐水的安慰剂溶液保持盲态。每天监测和调整PN和EN的相对量,以确保患者每天接受100%的处方热量。补充PN溶液或安慰剂PN将持续7天。在本研究期结束时,将停止研究干预,临床医生可以根据临床指征在两组中开具营养(PN或EN)处方。结局:这项拟议的初步研究将测量所有临床结局(例如死亡率)。这项初步研究的主要目的是在对照组和干预组之间实现30%的热量和蛋白质输送差异(600-100 kcal/d和20-30 g蛋白质/d)。还将在ICU中对研究患者进行前瞻性随访,以记录对研究干预的依从性、盲态维持和不良事件。这将使我们能够评估进行更大规模的最终试验的可行性。这项全面的决定性研究的结果将有助于回答以下基本问题: 对输送给营养风险ICU患者的能量和蛋白质量的影响,并将在多年来首次告知ICU中使用PN的当前实践。

项目成果

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Daren Keith Heyland其他文献

Daren Keith Heyland的其他文献

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{{ truncateString('Daren Keith Heyland', 18)}}的其他基金

Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU
危重疾病中的营养和运动(NEXIS 试验):ICU 中联合循环测力法和氨基酸的随机试验
  • 批准号:
    9906918
  • 财政年份:
    2017
  • 资助金额:
    $ 18.04万
  • 项目类别:
Nutrition and Exercise in Critical Illness (The NEXIS Trial): A Randomized Trial of Combined Cycle Ergometry and Amino Acids in the ICU
危重疾病中的营养和运动(NEXIS 试验):ICU 中联合循环测力法和氨基酸的随机试验
  • 批准号:
    9311124
  • 财政年份:
    2017
  • 资助金额:
    $ 18.04万
  • 项目类别:
Supplemental Parenteral Nutrition to Reduce Death in Malnourished ICU Patients
补充肠外营养可减少营养不良 ICU 患者的死亡
  • 批准号:
    8302851
  • 财政年份:
    2012
  • 资助金额:
    $ 18.04万
  • 项目类别:
Supplemental Parenteral Nutrition to Reduce Death in Malnourished ICU Patients
补充肠外营养可减少营养不良 ICU 患者的死亡
  • 批准号:
    8661267
  • 财政年份:
    2012
  • 资助金额:
    $ 18.04万
  • 项目类别:

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