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

NCT ID: NCT03365258

Last Updated: 2020-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-28

Study Completion Date

2020-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Critical Illness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Nutritional Risk

modified NUTRIC score ≥ 5

Group Type OTHER

Trophic feeding

Intervention Type DIETARY_SUPPLEMENT

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.

volume-based feeding

Intervention Type DIETARY_SUPPLEMENT

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

Low Nutritional Risk

modified NUTRIC score \< 5

Group Type OTHER

Trophic feeding

Intervention Type DIETARY_SUPPLEMENT

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.

volume-based feeding

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Trophic 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.

Intervention Type DIETARY_SUPPLEMENT

volume-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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Full caloric feeding

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 1\. NPO patients 2. Contraindication 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taichung Veterans General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Wang, Chen-Yu

Director of Medical Intensive Care Unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

王振宇

Taichung, 台中市, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

振宇 王, MD

Role: primary

886-4-23592525 ext. 3167

CHEN-YU WANG, MD

Role: backup

886-4-23592525 ext. 3167

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CF17249A

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intensive Care Unit Risk Score
NCT04661735 RECRUITING