NCT05628844

Brief Summary

Continuous enteral nutrition is used to feed patients in intensive care who are unable to eat normally. The goal of this observational study is to learn about the uptake of nutrients from feeding formula. The study method will first be applied in healthy persons to establish workability and normal values, then in patients in the intensive care unit to learn how nutrient uptake is affected by critical illness. The main questions this study aims to answer are:

  • what is the time course of uptake of phenylalanine (an amino acid) and glucose (a sugar) from enteral feeding formula given continuously over several hours
  • what is the time course of the filling volume of the stomach during continuous enteral feeding Participants receive feeding formula through a nasogastric feeding tube and blood samples are taken at short intervals to analyse uptake of nutrients into blood. Simultaneously, the filling volume of the stomach is measured by gastric ultrasound.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
8mo left

Started Jan 2023

Longer than P75 for all trials

Status
not yet recruiting

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 Progress84%
Jan 2023Dec 2026

First Submitted

Initial submission to the registry

November 17, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 29, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

December 2, 2022

Status Verified

November 1, 2022

Enrollment Period

4 years

First QC Date

November 17, 2022

Last Update Submit

November 29, 2022

Conditions

Critical Illness

Keywords

Continuous enteral feedingGastric volumeIntestinal absorptionEnteral nutritionNutritional support

Outcome Measures

Primary Outcomes (2)

  • Glucose and phenylalanine indicators

    Time series of isotopic and non-isotopic indicators of glucose and phenylalanine from enteral nutrition

    0-10 hours

  • Gastric volume

    Time series of gastric volume

    0-10 hours

Secondary Outcomes (1)

  • Plasma metabolites

    0-10 hours

Study Arms (2)

Healthy subjects

Healthy persons ≥ 18 yrs of age

Procedure: Continuous enteral feeding

Critically ill patients

Critically ill patients ≥ 18 yrs of age admitted to the ICU

Procedure: Continuous enteral feeding

Interventions

Continuous enteral feedingPROCEDURE

Enteral nutrition by continuous infusion for 10 hrs at a dose corresponding to 25 kcal/kg body weight/day

Also known as: Gastric ultrasound
Critically ill patientsHealthy subjects

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

ICU patients: patients admitted to an intensive care unit at Karolinska University Hospital Healthy subjects: volunteers from Stockholm metropolitan region

You may qualify if:

  • \- stable enteral nutrition of \>80% of measured or calculated energy expenditure by nasogastric feeding tube or gastrostomy

You may not qualify if:

  • enteral nutrition by postpyloric route such as jejunostomy or postpyloric tube
  • remaining ICU stay expected \< 12 hrs
  • ongoing bleeding that requires surgery/intervention or transfusion of \> 2 units red cells/24 hrs
  • inability to use feeding tube or arterial line
  • \- healthy volunteer
  • \- any condition or medication affecting nutrition or metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Liebau F, Kiraly E, Olsson D, Wernerman J, Rooyackers O. Uptake of dietary amino acids into arterial blood during continuous enteral feeding in critically ill patients and healthy subjects. Clin Nutr. 2021 Mar;40(3):912-918. doi: 10.1016/j.clnu.2020.06.018. Epub 2020 Jun 30.

    PMID: 32709553BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, plasma

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Felix Liebau, MD PhD

    Karolinska University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Liebau, MD PhD

CONTACT

felix.liebau@regionstockholm.se

Olav Rooyackers, Prof Phd

CONTACT

+46702069227olav.rooyackers@ki.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 17, 2022

First Posted

November 29, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

December 2, 2022

Record last verified: 2022-11