Name: a clinical trial assessing the safety, efficacy, and delivery of olive-oil-based three-chamber bags for parenteral nutrition
Uploaded: 2019-09-20T12:30:00
Description: Watch this Scientific Journal Video about A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition at JoVE.com

这项研究由百特医疗公司赞助和资助，该公司是OliClinomel N4的制造商/许可方。ProScribe 的使用符合良好出版实践的全球准则。

针对这一前瞻性、随机化、多中心化、主动控制化、平行组调查试验，上海市第六人民医院伦理委员会批准了该研究方案。
1. 患者招募和注册
<ol><li>根据协议中指定的包含标准招募患者。寻求患者的知情同意，并在预定手术前3天内进行筛查评估。</li>
	<li>根据随机化时间表，对两种研究处理（基于橄榄油的3CBsor大豆油基CoBs）中的一个进行随机登记。<ol>
<li>随机化接受手术?...

<ol>
	<li>Jeejeebhoy, K. N. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Parenteral+nutrition+in+the+intensive+care+unit.">Parenteral nutrition in the intensive care unit.</a> Nutrition Reviews. 70 (11), 623-630 (2012).</li><li>Simmer, K., Rakshasbhuvankar, A., Deshpande, G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Standardised+parenteral+nutrition.">Standardised parenteral nutrition.</a> Nutrients. 5 (4), 1058-1070 (2013).</li><li>Vanek, V. W., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A.S.P.E.N.+position+paper:+Clinical+role+for+alternative+intravenous+fat+emulsions.">A.S.P.E.N. position paper: Clinical role for alternative intravenous fat emulsions.</a> Nutrition in Clinical Practice. 27 (2), 150-192 (2012).</li><li>Singer, P., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=ESPEN+guidelines+on+parenteral+nutrition:+Intensive+care.">ESPEN guidelines on parenteral nutrition: Intensive care.</a> Clinical Nutrition. 28 (4), 387-400 (2009).</li><li>Calder, P. C., Jensen, G. L., Koletzko, B. V., Singer, P., Wanten, G. J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Lipid+emulsions+in+parenteral+nutrition+of+intensive+care+patients:+Current+thinking+and+future+directions.">Lipid emulsions in parenteral nutrition of intensive care patients: Current thinking and future directions.</a> Intensive Care Medicine. 36 (5), 735-749 (2010).</li><li>Umpierrez, G. E., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=A+double-blind,+randomized+clinical+trial+comparing+soybean+oil-based+versus+olive+oil-based+lipid+emulsions+in+adult+medical-surgical+intensive+care+unit+patients+requiring+parenteral+nutrition.">A double-blind, randomized clinical trial comparing soybean oil-based versus olive oil-based lipid emulsions in adult medical-surgical intensive care unit patients requiring parenteral nutrition.</a> Critical Care Medicine. 40 (6), 1792-1798 (2012).</li><li>Jia, Z. Y., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Safety+and+efficacy+of+an+olive+oil-based+triple-chamber+bag+for+parenteral+nutrition:+A+prospective,+randomized,+multi-center+clinical+trial+in+China.">Safety and efficacy of an olive oil-based triple-chamber bag for parenteral nutrition: A prospective, randomized, multi-center clinical trial in China.</a> Nutrition Journal. 14, 119 (2015).</li><li>Tetzlaff, J. M., Moher, D., Chan, A. W. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Developing+a+guideline+for+clinical+trial+protocol+content:+Delphi+consensus+survey.">Developing a guideline for clinical trial protocol content: Delphi consensus survey.</a> Trials. 24 (13), 176 (2012).</li><li>Glasser, S. P., Howard, G. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Clinical+trial+design+issues:+At+least+10+things+you+should+look+for+in+clinical+trials.">Clinical trial design issues: At least 10 things you should look for in clinical trials.</a> Journal of Clinical Pharmacology. 46 (10), 1106-1115 (2006).</li><li>Ruikar, V. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Interactive+voice/Web+response+system+in+clinical+research.">Interactive voice/Web response system in clinical research.</a> Perspectives in Clinical Research. 7 (1), 15-20 (2016).</li><li>Kulkarni, P. M., Meadows, E. S., Ahuja, S., Muram, D., Plouffe, L. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Rationale+for+a+non-inferiority+clinical+trial+design+focused+on+subpopulations.">Rationale for a non-inferiority clinical trial design focused on subpopulations.</a> Current Medical Research and Opinion. 20 (10), 1641-1647 (2004).</li><li>Efird, J. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Blocked+randomization+with+randomly+selected+block+sizes.">Blocked randomization with randomly selected block sizes.</a> International Journal of Environmental Research and Public Health. 8 (1), 15-20 (2011).</li><li>Teitelbaum, D. H., et al. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Proceedings+From+FDA/A.S.P.E.N.+Public+Workshop:+Clinical+Trial+Design+for+Intravenous+Fat+Emulsion+Products.">Proceedings From FDA/A.S.P.E.N. Public Workshop: Clinical Trial Design for Intravenous Fat Emulsion Products.</a> Journal of Parenteral and Enteral Nutrition. 39 (7), 768-786 (2015).</li><li>Pocock, S. J., Clayton, T. C., Stone, G. W. <a target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Search&doptcmdl=Citation&defaultField=Title+Word&term=Challenging+issues+in+clinical+trial+design:+Part+4+of+a+4-Part+series+on+statistics+for+clinical+trials.">Challenging issues in clinical trial design: Part 4 of a 4-Part series on statistics for clinical trials.</a> Journal of the American College of Cardiology. 66 (25), 2886-2898 (2015).</li></ol>

随机临床试验方案是一种多用途文档。它不仅为调查人员进行审判提供指导，而且使道德委员会和机构审查委员会了解为保护参与者的安全和利益而采取的适当措施。正确的设计对于临床试验的成功至关重要。人们经常注意到，一个试验的设计与其成功/失败8有关。
此外，选择干预和控制组是协议设计的关键步骤。复合PN是目前对无法从饮食或肠道营养中获?...

肠外营养是综合治疗广泛适应症的重要组成部分，如大胃肠道手术、暂时性肠不耐受、严重烧伤、昏迷;或用于危重病人。静脉注射（IV）营养配方的改进和关于实施治疗的知识进步使静脉营养安全且临床上有效。这些特征在代谢压力患者1中尤其重要。
父母营养通常通过混合医院药房中复合的营养成分给患者。从单个成分中复合总肠外营养解决方案是一个多步骤、耗时的过程，与更大的人为错误风险相关。最近，已经开发出三室袋 （3CB） 系统，其中单个部件由非永久性易碎密封件分离。3CB 的内容包括葡萄糖溶液、氨基酸溶液、脂质乳液，带或不带电解质。在进行管理之前，分离 3CB 各部件的密封件被打破，使腔室的部件得以混合。3CB 的优势包括提高组件的物理化学保质期，减少制备过程中的污染程度，以及减少制备 PN 产品2所需的步骤。
脂乳是PN配方中的重要成分;它可以产生不同的临床效果，取决于成分脂肪酸。大豆油基脂乳液主要由长链亚油酸（+-6多不饱和脂肪酸[+-6PUFA]）组成，主要是原发炎。实验数据表明，*-6富含PUFA的脂质乳液可能放大压力和创伤期间的炎症反应，并增加感染率3。另一方面，橄榄油基脂乳液，由长链油酸（+-9单不饱和脂肪酸，[+-9MUFAs]）组成，对免疫系统有中性反应3，4。用橄榄油基+-9MUFA替代大豆油基+-6PUFAs，可以使PN安全，并进一步拓宽其临床应用5，6。然而，这方面的临床数据有限。
因此，本研究旨在评估亚油酸含量不同的两种不同脂质乳液的感染率，以及评估 3CB 与 CoB 相比，在提供Pn。评估是在计划接受手术的成人住院病人身上进行的，这些病人肠内营养要么不可能，要么不足，要么不可取。

a clinical trial assessing the safety, efficacy, and delivery of olive-oil-based three-chamber bags for parenteral nutrition

在住院的成人患者中，使用橄榄油基三室袋 （3CB） 和大豆油基复合袋 （CoBs） 制备的肠外营养 （PN） 的疗效和安全差异存在有限的证据。我们设计了一种多中心、随机、前瞻性、开放标签、非劣质方案，以比较在手术期间需要PN的中国成年患者的橄榄油基3CB和大豆油基CoB配方的疗效、安全性和分布情况。干预。根据随机化代码，对受试者进行随机访问，使用交互式语音或基于网络的识别系统进行其中一种研究处理。根据研究地点和外科类别进一步分层。两个治疗组都收到了同样数量的卡路里和蛋白质。此外，两项研究处理含有类似的氨基酸成分成分。两种PN配方的唯一区别是脂质组成。研究治疗的持续时间至少为5天，手术后最多14天。主要疗效终点是研究的第5天血清前白蛋白水平。如果治疗差的95%置信区间（CI）的下限的反日志至少为0.80，则证明不自卑。其他疗效措施包括治疗准备时间;实现口服营养的耐久性;相关的感染并发症;住院时间;和实验室评估营养，炎症，代谢和氧化应激的标记。共有458名患者参加了这项研究。结果表明，橄榄油基3CB除了耐受性好外，还不如大豆棒。发现以橄榄油为基础的3CB组的感染率明显较低。因此，本研究可作为今后脂质乳液和3CB研究的参考。

患者处置 在480名同意的患者中，共有458名患者被登记并随机参与研究。ITT人群包括所有随机患者，其中226人构成测试组，232名对照组。安全人群包括453名患者，其中222人属于对照组，231人属于对照组。修改后的治疗意向组共有443名患者，其中219人属于对照组，224人属于对照组（图4）。
共有373名患者组成每协议（PP）人群，其中183例在测?...

Watch this Scientific Journal Video about A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition at JoVE.com

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

在这里，我们提出了一个协议，用于比较橄榄油基3CB和大豆油基CoB配方在需要肠外营养的成年人的功效、安全性和交付。结果表明，与大豆配方相比，以橄榄油为基础的3CB是非劣质的，耐受性好。

一项临床试验，评估基于橄榄油的三腔袋的亲子营养的安全性、有效性和交付

Limited evidence exists to precisely estimate efficacy and safety differences between parenteral nutrition (PN) prepared using olive-oil-based ...

该协议为未来多个中心、室室袋提供了模板。该方案具有平衡性和有效性，即临床可操作性，为今后的研究提供实用模型。这种方法可以作为研究父母管理和医疗营养的参考，特别是三室袋。奇怪是很难设计和实现。引用类似的协议可能是首次进入此字段的某人的快捷方式。本研究的部分设计实现可以通过文本清楚地呈现。为了确保每个治疗的正确剂量，并保持处方的一致性，给每个研究网站一个表，其中包含不同重量的确切PM成分。通过控制泵通过外围静脉导管为每位参与者进行治疗。如果无法通过外设 IV 进行输液或不可取，则通过外设插入的中央导管或中央 IV 线路注入研究处理。在第一小时内逐渐将流量提高至每小时 50 至 100 毫升，并在至少 5 天和 14 天内提供 12 至 22 小时的治疗。第1天至第5天，只进行研究治疗。为了评估主要疗效结果测量，血清前白蛋白水平，在第5天，从外周四研究参与者的反向附属物以及评估时间表中指明的时间点获取2至3毫升外周外静脉血样。将血液在4摄氏度下储存长达4小时，然后将样品转移到中央实验室，以分析疗效参数。要评估尿液输出的主要疗效结果测量，请根据第5天收集尿液6小时，并按照评估时间表进行收集。在将样品储存在 4 摄氏度之前，记录适用处理日收集的体积。然后将尿液收集中的等分转移到中央实验室，用于分析功效参数。对于治疗的安全性评估，调查参与者的任何不良或严重不良事件，并进行重要体征评估和身体检查。然后按照时间表执行任何其他实验室评估。第6天，直到研究期结束，开始在研究治疗中添加液体口服营养，以满足计算的每日营养需求。一旦患者接受所计算的每日营养需求的至少80%，或在完成第14天研究治疗时，停止研究治疗;以先到者为准。完成或终止治疗后，按照时间表为学员执行适当的治疗结束程序。在这项具有代表性的研究中，共有62%的患者接受了一次平均持续时间为3小时的高复杂手术。在2组进行年龄"性别"无手术""中等复杂手术"和高复杂度手术的分组分析时，也观察到了类似的趋势。研究发现，总体感染率较低，对照组患者的感染率明显高于测试组。研究中最常见的感染是肺部感染，其次是切口和伤口感染。研究治疗的准备时间也明显低于所有评估日对照组。首先，在研究设计之前，我们应考虑临床安全性和可行性。另一点是，最大限度地减少不同边的差异对于新兴中心研究的构建协议设计非常重要。

Education

Research

JoVE Core

JoVE Journal

Statistics

Nursing

Medicine

Pharmacology

Unit 1

Measures of Relative Standing

Estimates

Probability Distributions

Measures of Variation

Distributions

Statistics in Practice

Infection Prevention and Control

Analysis of Variance

General Pharmacological Principles

Correlation and Regression

Hypothesis Testing

SCIENTISTS IN ACTION

Clinical Testing and Spinal Cord Removal in a Mouse Model for Amyotrophic Lateral Sclerosis (ALS)

Clinical Testing and Spinal Cord Removal in a Mouse Model for Amyotrophic Lateral Sclerosis ALS

临床试验和脊髓去除在肌萎缩性侧索硬化症的小鼠模型（ALS）

Amyotrophic lateral sclerosis (ALS) is a fatal neurodegenerative disorder resulting in progressive degeneration of motoneurons. Peak of onset is around 60 ...

科研

医学

Osmotic Drug Delivery to Ischemic Hindlimbs and Perfusion of Vasculature with Microfil for Micro-Computed Tomography Imaging

药物输送到微型计算机断层扫描成像缺血后肢血管灌注与微滤渗透

Preclinical research in animal models of peripheral arterial disease plays a vital role in testing the efficacy of therapeutic agents designed to ...

Testing the Efficacy of Pharmacological Agents in a Pericardial Target Delivery Model in the Swine

药理试验药物的疗效在心包目标交付模型在猪

To date, many pharmacological agents used to treat or prevent arrhythmias in open-heart cases create undesired systemic side effects. For example, ...

Detection of Disease-associated &#945;-synuclein by Enhanced ELISA in the Brain of Transgenic Mice Overexpressing Human A53T Mutated &#945;-synuclein

Detection of Disease-associated ÃƒÅ½Ã‚Â±-synuclein by Enhanced ELISA in the Brain of Transgenic Mice Overexpressing Human A53T Mutated ÃƒÅ½Ã‚Â±-synuclein

发现疾病相关的α突触核蛋白通过增强ELISA在转基因小鼠表达人A53T的突变脑α突触核蛋白

In addition to established methods like Western blot, new methods are needed to quickly and easily quantify disease-associated &#945;-synuclein (&#945;SD) ...

Phosphorus-31 Magnetic Resonance Spectroscopy: A Tool for Measuring In Vivo Mitochondrial Oxidative Phosphorylation Capacity in Human Skeletal Muscle

Phosphorus-31 Magnetic Resonance Spectroscopy: A Tool for Measuring In Vivo Mitochondrial Oxidative Phosphorylation Capacity in Human Skeletal Muscle

磷31磁共振波谱分析：一种测量工具<em&gt;在体内</em&gt;线粒体氧化磷酸化能力人骨骼肌

Skeletal muscle mitochondrial oxidative phosphorylation (OXPHOS) capacity, which is critically important in health and disease, can be measured in vivo ...

Optimized LC-MS/MS Method for the High-throughput Analysis of Clinical Samples of Ivacaftor, Its Major Metabolites, and Lumacaftor in Biological Fluids of Cystic Fibrosis Patients

经优化的 LC/ms 方法对囊性纤维化患者 Ivacaftor 及其主要代谢物和 Lumacaftor 的高通量分析

Defects in the cystic fibrosis trans-membrane conductance regulator (CFTR) are the cause of cystic fibrosis (CF), a disease with life-threatening ...

Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis

在生物标志物分析临床试验场单次抽血时，准备外周血单核细胞颗粒和血浆

Analysis of biomarkers in peripheral blood is becoming increasingly important in clinical trials to establish proof of mechanism to evaluate effects of ...

Assessing Whole-Body Lipid-Handling Capacity in Mice

评估小鼠全身脂质处理能力

Assessing lipid metabolism is a cornerstone of evaluating metabolic function, and it is considered essential for in vivo metabolism studies. Lipids are a ...

Direct Drug Delivery to Kidney via the Renal Artery

通过肾脏动脉直接向肾脏输送药物

There is a need for directed injections to enable increased and specific renal exposure for efficient evaluation of drug targets in the renal research ...

Predicting Prognosis in Acute Heart Failure Using Phase Angle & BIVA Z-Scores

Clinical Application of Phase Angle and BIVA Z-Score Analyses in Patients Admitted to an Emergency Department with Acute Heart Failure

Unveiling Prognostic Indicators in Heart Failure - The Role of Phase Angle and Bioelectrical Impedance Analysis (Video) | JoVE

相位角和BIVA Z评分分析在急诊科急性心力衰竭患者中的临床应用

Acute heart failure is characterized by neurohormonal activation, which leads to sodium and water retention and causes alterations in body composition, ...