NCT04868318

Brief Summary

The advantage of higher protein intake has been pointed for critically ill patients. However, it is not easy to achieve no overfeeding but adequate protein intakes for critically ill patients. It is thus important to conduct a strategy to deliver an adequate protein under but no overfeeding for critically ill patients. The purpose of this study is to investigate the association of protein intakes with clinical outcomes by delivering high-protein pre-digested enteral formula to surgical critically ill patients. We are going to recruit 160 surgical critically ill patients. Patients would be randomly assigned to either control or experimental group. Very-high protein pre-digested formula (37% of energy) would be given to the experimental group, while standard-high protein formula (16% of energy) would be given to the control group for at least 3 days to up to 7 days. The patients' data were collected or calculated and included basic characteristics, mean energy and protein intakes, clinical outcomes (APACHE II score, comorbidities, days in hospital to ICU admission, length of ventilator dependence, hospital and ICU stays, and survival days). We anticipated that the results of this study could provide the benefit of high protein delivery on clinical outcomes for critically ill patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

May 10, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

April 22, 2021

Last Update Submit

February 14, 2022

Conditions

Enteral NutritionCritical Illness

Outcome Measures

Primary Outcomes (2)

  • Survival rate

    The percentage of people in two-arm group was still alive for 28-days of time after admission to ICU.

    28 days

  • Survival rate

    The percentage of people in two-arm group was still alive for 14-days of time after admission to ICU.

    14 days.

Secondary Outcomes (4)

  • ICU days

    28 days

  • Hospital days

    28 days

  • Length of ventilator

    28 days

  • Nitrogen balance

    7 days

Study Arms (2)

VHP(very-high protein) group

EXPERIMENTAL

In VHP(very-high protein) group, we will provide pre-digested formula of 37% protein to the experimental group for at least 3 days to up to 7 days.

Other: Very-high protein enteral formula

SHP(standard-high protein) group

ACTIVE COMPARATOR

SHP(standard-high protein) group is the control group, standard-high protein formula (16% of energy) would be given to the control group for at least 3 days to up to 7 days.

Other: Standard-high protein enteral formula

Interventions

Very-high protein enteral formulaOTHER

Peptamen® Intense VHP (37% protein)

VHP(very-high protein) group
Standard-high protein enteral formulaOTHER

Peptamen® (16% protein)

SHP(standard-high protein) group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older.
  • Those who have stayed in the surgical intensive care unit for 24 hours or more.

You may not qualify if:

  • Those who cannot supply enteral nutrition within 3 days due to disease or unstable clinical conditions.
  • Those who have been fed for less than three days due to disease or unstable clinical conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PS Lim

Taichung, 435, Taiwan

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pei-Rong Li

    Tungs' Taichung Metroharbor Hospital

    PRINCIPAL INVESTIGATOR

  • Yi-Chia Huang

    Chung Shan Medical University

    PRINCIPAL INVESTIGATOR

  • Shung-Sheng Tsou

    Tungs' Taichung Metroharbor Hospital

    PRINCIPAL INVESTIGATOR

  • Li-Wa Liao

    Tungs' Taichung Metroharbor Hospital

    STUDY DIRECTOR

  • Feng-Chan Shi

    Tungs' Taichung Metroharbor Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 30, 2021

Study Start

May 10, 2021

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)