ClinicalTrials.gg
Status unknownNCT03365258Updated Feb 7, 2020

The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients

An interventional study of Trophic feeding and volume-based feeding in Critical Illness, sponsored by Taichung Veterans General Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2020-02-07.

Sponsored by Taichung Veterans General Hospital · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Feb 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
20 Years to 100 Years
Sex
All
01

Study summary

Malnutrition is very common in critically ill patients. It is quite important to evaluate nutritional status precisely. Heyland et al firstly reported NUTRIC score including age, APACHE II score, SOFA score, number of commorbidities, days from hospital to ICU admission and IL-6. Because the IL-6 is not routinely checked at ICU. A modified NUTRIC score without IL-6 is more practical. Previous studies showed lower in-hospital mortality in higher nutritional risk patients with higher caloric intake compared with lower caloric intake. However, there is still controversial regarding the in-hospital mortality between full caloric feeding and permissive underfeeding in critically ill patients. Herein the investigators conduct a study to investigate what kinds of nutritional supplements will decrease in-hospital mortality in different nutritional risk patients.

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Conditions studied

  • Critical Illness

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03

In context

Critical Illness

1,780 studies on the registry are indexed under Critical Illness; 442 are open to participants now.

This study's planned enrollment of 150 is above the median of 90 across 926 interventional studies indexed under Critical Illness.

Browse Critical Illness studies →

Lead sponsor

Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

    1. Medical intensive care unit patients 2. age elder than 20 years old 3. Intubated with ventilator support patients 4. Predicted ICU stay longer than 72 hours

Exclusion criteria

Exclusion Criteria:

    1. NPO patients 2. for enteral feeding 3. TPN use 4. Upper or lower GI bleeding patients 5. Feeding with gastrostomy or Jejunostomy patients 6. Metoclopramide related EPS or Torsades de pointes history
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    High Nutritional Risk

    modified NUTRIC score ≥ 5

    Dietary Supplement: Trophic feeding · Dietary Supplement: volume-based feeding

  • Other
    Low Nutritional Risk

    modified NUTRIC score \< 5

    Dietary Supplement: Trophic feeding · Dietary Supplement: volume-based feeding

Interventions

  • Dietary supplementTrophic feeding

    Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0-\>Day 6). The definition of trophic feeding is continue feeding with feeding rate: 20 kcal/hr.

  • Dietary supplementvolume-based feeding

    Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0-\>Day 6). The definition Volume-based feeding also use continue feeding by feeding protocol

    Also known as: Full caloric feeding

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What researchers measure

Primary outcomes

  1. In-hospital mortality

    mortality or discharge

    Time frame: 90 days

07

Study locations

1 of 1 sites recruiting
  • 王振宇
    Taichung City, 台中市 433, Taiwan
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for May 2020, 29 months after the start.

Of 400 non-industry interventional studies with no phase under Critical Illness, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's planned 29 months is above that.

Counting every sponsor, half of 404 studies reached it within 21 months; a quarter within 12 and three quarters within 40.

Critical Illness covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 28, 2017
First posted
Dec 7, 2017
StartActual
Dec 28, 2017
Primary completionEst.
May 31, 2020
CompletionEst.
May 31, 2020
Last update
Feb 7, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03365258
Responsible party
Wang, Chen-Yu (Director of Medical Intensive Care Unit, Taichung Veterans General Hospital) — Principal investigator
First posted
Dec 7, 2017
Start date
Dec 28, 2017
Primary completion
May 31, 2020 (estimated)
Completion
May 31, 2020 (estimated)
Last update
Feb 7, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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