NCT03761680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 22, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 3, 2018

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 14, 2023

Status Verified

March 1, 2023

Enrollment Period

3.1 years

First QC Date

November 23, 2018

Last Update Submit

March 13, 2023

Conditions

Malnutrition

Keywords

Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Average intake of energy / day (kcal, % of calculated daily requirement)

    throughout the hospitalization: min. 3 to max. 30 days

Secondary Outcomes (8)

  • Average intake of protein /day (g, % of calculated daily requirement)

    throughout the hospitalization: min. 3 to max. 30 days

  • 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

  • Changes in body weight (kg)

    throughout the hospitalisation: min. 3 to max. 30 days

  • Development of appetite visual analogue scale (VAS)-score (cm)

    throughout the hospitalisation: min. 3 to max. 30 days

  • +3 more secondary outcomes

Study Arms (2)

MEDPass Group

EXPERIMENTAL

Allocation of ONS in the MEDPass mode

Dietary Supplement: MEDPass mode of administration

Control Group

ACTIVE COMPARATOR

Patients receive ONS between meals or at their request as usual

Dietary Supplement: Control Intervention

Interventions

MEDPass mode of administrationDIETARY_SUPPLEMENT

Allocation of 50 ml of ONS four times per day distributed with the medication rounds

MEDPass Group
Control InterventionDIETARY_SUPPLEMENT

Patients receive ONS between meals or at their request as usual

Control Group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital, Berne, Facility Tiefenau

Bern, Canton of Bern, 3004, Switzerland

Location

Related Publications (2)

  • Kurmann S, Reber E, Schonenberger KA, Schuetz P, Uhlmann K, Vasiloglou MF, Schoenenberger AW, Bertschi D, Sterchi AB, Stanga Z. MEDPass versus conventional administration of oral nutritional supplements - A randomized controlled trial comparing coverage of energy and protein requirements. Clin Nutr. 2023 Feb;42(2):108-115. doi: 10.1016/j.clnu.2022.11.015. Epub 2022 Dec 5.

    PMID: 36525797DERIVED

  • Kurmann S, Reber E, Vasiloglou MF, Schuetz P, Schoenenberger AW, Uhlmann K, Sterchi AB, Stanga Z. Energy and protein intake in medical and geriatric inpatients with MEDPass versus conventional administration of oral nutritional supplements: study protocol for the randomized controlled MEDPass Trial. Trials. 2021 Mar 16;22(1):210. doi: 10.1186/s13063-021-05145-4.

    PMID: 33726841DERIVED

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Zeno Stanga, Prof.Dr.med.

    Insel Gruppe AG, University Hospital Bern

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, open-label, clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

December 3, 2018

Study Start

November 22, 2018

Primary Completion

December 30, 2021

Study Completion

December 31, 2021

Last Updated

March 14, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)