NCT02678325

Brief Summary

The objective of this study is to compare the difference in daily protein intake of critically ill patients in two standardized enteral nutrition formulas (20% versus 33% percent) with the same caloric density of 1.2 kcal/ml. The total amount of protein taken in on day four after starting the early enteral feeding is defined as primary endpoint.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

May 21, 2016

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 30, 2021

Status Verified

March 1, 2021

Enrollment Period

3.6 years

First QC Date

February 5, 2016

Last Update Submit

March 29, 2021

Conditions

High Enteral Protein NutritionMuscle BreakdownAutophagy

Outcome Measures

Primary Outcomes (1)

  • The amount of protein

    The amount of protein administered on day four after starting the early enteral feeding.

    4 days

Secondary Outcomes (5)

  • The total amount of calories

    4 days

  • The nitrogen balance on day four

    4 days

  • Gastric residual Content in ml

    4 days

  • Number of diarrhea events

    4 days

  • occurence of constipation as measured in time without defecation

    4 days

Study Arms (2)

Standardized normal protein enteral nutrition formula

ACTIVE COMPARATOR

Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 20% of the total caloric intake

Other: Standardized normal protein enteral nutrition

Standardized high protein enteral nutrition formula

EXPERIMENTAL

Standardized enteral nutrition formula with a caloric density of 1.2 kcal/ml and protein percentage 33% of the total caloric intake

Other: Standardized high protein enteral nutrition

Interventions

Standardized high protein enteral nutritionOTHER

A double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration on muscle breakdown and mortality.

Standardized high protein enteral nutrition formula
Standardized normal protein enteral nutritionOTHER

double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration (compared to normal enteral protein administration) on muscle breakdown and mortality.

Standardized normal protein enteral nutrition formula

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (age 18 years or older)
  • expected stay at the ICU of four days upon admittance or longer
  • expected enteral feeding during at least four days.

You may not qualify if:

  • BMI ≤ 18
  • Mechanical intestinal obstruction
  • Intestinal perforation
  • Severely impaired liver function
  • Terminal state of consuming disease
  • Noradrenaline ≥0.5µg/kg BW/min
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

Related Publications (1)

  • Tedeschi-Jockers F, Reinhold S, Hollinger A, Tuchscherer D, Kiss C, Gantner L, Ledergerber K, Zimmermann S, Scheuzger J, Huber J, Siegemund M. A new high protein-to-energy enteral formula with a whey protein hydrolysate to achieve protein targets in critically ill patients: a prospective observational tolerability study. Eur J Clin Nutr. 2022 Mar;76(3):419-427. doi: 10.1038/s41430-021-00956-9. Epub 2021 Jun 24.

    PMID: 34168292DERIVED

Study Officials

  • Martin Siegemund, Prof. Dr. MD

    Deputy Chief Physician, Surgical Intensive Care Unit, University Hospital Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

May 21, 2016

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 30, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)