Malnutrition
Conditions
Keywords
Malnutrition
Brief summary
The aim of the randomized-controlled, single-center MEDPass trial is to assess the effects of MEDPass versus conventional administration of oral nutritional supplements (ONS) on energy and protein intake in medical and geriatric inpatients.
Detailed description
Disease related malnutrition (DRM) in hospitalized patients is a common problem.The oral nutritional support with ONS is one of the first and most common treatment approach in the patients at nutritional risk. Treatment with ONS may reduce mortality and complications in hospitalized patients. There are no standards on the type of administration of ONS in terms of timing throughout the day leading to individual approaches. ONS are conventionally served as snacks by nurses, nursing aids or gastronomy personnel between the main meals. The MEDPass-mode offers a different approach by serving ONS together with the medication, three or four times per day, in unusually small portions. Preliminary trials suggest that compliance and cost effectiveness may be improved with the MEDPass-mode. Enhancing compliance to ONS may not consequently lead to improved total energy and protein intake throughout the day. There has never been a large trial in which total energy- and protein intake of the subjects was studied consequently and systematically throughout the hospitalization. Therefore, this trial will bridge this gap by studying total energy- and protein intake as primary outcomes.
Interventions
DIETARY_SUPPLEMENTMEDPass mode of administration
Allocation of 50 ml of ONS four times per day distributed with the medication rounds
DIETARY_SUPPLEMENTControl Intervention
Patients receive ONS between meals or at their request as usual
Sponsors
Bern University of Applied Sciences
Insel Gruppe AG, University Hospital Bern
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized, controlled, open-label, clinical trial
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Nutritional risk screening (NRS-2002) total score ≥3 points according to routine screening at admission within 72 hours * Expected hospital LOS ≥3 days after screening (as estimated by the treating physician) * Patient qualifies for ONS and approves prescription * Age \>18 years * Willingness and ability to provide informed consent
Exclusion criteria
* Initially admitted to critical care unit * Immediate post-operative phase (\<7 days post-surgery) * Dysphagia with the inability to swallow liquids * Supplemental enteral and/or parenteral nutrition * Admitted with, or scheduled for, total parenteral nutrition or tube feeding * Mini Mental State examination \< 16 points * hospitalized due to anorexia nervosa * hospitalized due to acute pancreatitis * hospitalized due to acute liver failure * cystic fibrosis * patients after gastric bypass surgery * patients with short bowel syndrome * terminal condition (end of life situation) * poor skills in German language (study language)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average intake of energy / day (kcal, % of calculated daily requirement) | throughout the hospitalization: min. 3 to max. 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average intake of ONS / day (ml) | throughout the hospitalisation: min. 3 to max. 30 days | — |
| Development of hand grip strength (kg) | throughout the hospitalisation: min. 3 to max. 30 days | Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. Evaluated with the JAMAR® Hydraulic Hand Dynamometer (Patterson Medical, Warrenville, IL, USA). If possible, measurements are conducted on the dominant hand, three times with a break of at least 30 seconds between the measurements. The highest value is noted. Accuracy: 0.5 kg. Range: 0.0 - 90.0 kg |
| Changes in body weight (kg) | throughout the hospitalisation: min. 3 to max. 30 days | Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. Accuracy: 0.1 kg. |
| Average intake of protein /day (g, % of calculated daily requirement) | throughout the hospitalization: min. 3 to max. 30 days | — |
| Development of nausea visual analogue scale (VAS)-score (cm) | throughout the hospitalisation: min. 3 to max. 30 days | Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown. The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable. Accuracy: 0.1 cm. |
| Hospital length of stay (LOS) | hospitalization, max. 30 days | — |
| Mortality | 30 days | — |
| Development of appetite visual analogue scale (VAS)-score (cm) | throughout the hospitalisation: min. 3 to max. 30 days | Monitored at day 1, day 8, day 15, 22 and 29 or at discharge if at least 5 days after the last measurement have past. The present day is the focus of the assessment. On the front of the scale which is visible to the patient, only smileys are shown. The scale on the back ranges from 0-10 cm to objectify the measurement with 10 cm being the most desirable. Accuracy:0.1 cm. |
Countries
Switzerland
Outcome results
None listed