Kurmann Silvia, Reber Emilie, Vasiloglou Maria F, Schuetz Philipp, Schoenenberger Andreas W, Uhlmann Katja, Sterchi Anna-Barbara, Stanga Zeno
Health Division, Department of Nutrition and Dietetics, Research and Development, Bern University of Applied Sciences, Murtenstrasse 10, CH-3010, Bern, Switzerland.
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, and University of Bern, Freiburgstrasse 15, CH-3010, Bern, Switzerland.
Trials. 2021 Mar 16;22(1):210. doi: 10.1186/s13063-021-05145-4.
Disease-related malnutrition is highly prevalent in hospitalized medical and geriatric inpatients. It is associated with negative outcomes such as muscle wasting, decline of functional status, and increased morbidity and mortality. Oral nutritional supplements (ONS) are frequently used in nutritional therapy to increase intake. However, compliance to ONS is often limited and maybe improved by prescribing ONS in small portions timed with the medication (MEDPass). However, it is unknown whether the MEDPass administration enhances patients' total energy and protein intake.
The MEDPass Trial is a randomized, controlled, open-label superiority trial. Patients in the MEDPass group receive 50 ml of ONS four times per day, distributed with the medication rounds. Patients in the control group receive ONS between meals. The primary outcome is average daily energy intake (% of calculated daily requirement). For our power analysis, we assumed that administration of ONS in the MEDPass administration mode increases energy intake by at least 10% (i.e., by 200 kcal for an average energy requirement of 2200 kcal/day). Thus, with the inclusion of 200 patients, this trial has 80% power to demonstrate that intervention group patients have an average intake of 2200 kcal/day (SD 500 kcal) versus 2000 kcal/day (SD 500 kcal) in control group patients. Energy and protein intakes from ONS and all food consumed are monitored continuously throughout the hospital stay and are statistically compared to the patient's requirements. Secondary outcomes include average daily protein intake (% of calculated daily requirement), average intake of ONS/day, the course of body weight, handgrip strength, appetite, and nausea. Furthermore, hospital length of stay and 30-day mortality are assessed. The primary statistical analysis will be performed as an intention-to-treat analysis adjusted for the stratification factors used in randomization.
To our knowledge, this is the first randomized controlled trial assessing total energy and protein intake for the entire hospitalization period in patients receiving MEDPass versus conventional ONS administration. Thus, the MEDPass Trial will fill a gap and answer this relevant clinical question.
ClinicalTrials.gov NCT03761680 . Registered on 3 December 2018. Kofam.ch SNCTP000003191 . Registered on 15 October 2018.
疾病相关营养不良在住院的内科和老年患者中非常普遍。它与肌肉萎缩、功能状态下降以及发病率和死亡率增加等不良后果相关。口服营养补充剂（ONS）常用于营养治疗以增加摄入量。然而，ONS的依从性往往有限，通过与用药时间同步分小份开具ONS（MEDPass）可能会提高依从性。然而，MEDPass给药方式是否能提高患者的总能量和蛋白质摄入量尚不清楚。
MEDPass试验是一项随机、对照、开放标签的优效性试验。MEDPass组的患者每天分4次每次接受50毫升ONS，与用药查房同时进行。对照组的患者在两餐之间接受ONS。主要结局是平均每日能量摄入量（占计算出的每日需求量的百分比）。对于我们的功效分析，我们假设MEDPass给药模式下的ONS给药可使能量摄入量至少增加10%（即对于平均能量需求为2200千卡/天的患者增加200千卡）。因此，纳入200名患者后，该试验有80%的功效证明干预组患者的平均摄入量为2200千卡/天（标准差500千卡），而对照组患者为2000千卡/天（标准差500千卡）。在整个住院期间持续监测ONS和所有摄入食物的能量和蛋白质摄入量，并与患者的需求量进行统计学比较。次要结局包括平均每日蛋白质摄入量（占计算出的每日需求量的百分比）、每日ONS平均摄入量、体重变化过程、握力、食欲和恶心情况。此外，评估住院时间和30天死亡率。主要统计分析将作为意向性分析进行，并根据随机化中使用的分层因素进行调整。
据我们所知，这是第一项评估接受MEDPass与传统ONS给药的患者在整个住院期间总能量和蛋白质摄入量的随机对照试验。因此，MEDPass试验将填补空白并回答这个相关的临床问题。
ClinicalTrials.gov NCT03761680。于2018年12月3日注册。Kofam.ch SNCTP000003191。于2018年10月15日注册。
