The Impact of Intervention With High-protein Enteral Formula in SICU.

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.

Conditions

• Enteral Nutrition
• Critical Illness

Interventions

OTHER

Very-high protein enteral formula

Peptamen® Intense VHP (37% protein)

OTHER

Standard-high protein enteral formula

Peptamen® (16% protein)

Sponsors & Collaborators

• Tungs' Taichung Metroharbour Hospital

  lead OTHER

Principal Investigators

• Pei-Rong Li · Tungs' Taichung Metroharbor Hospital

• Yi-Chia Huang · Chung Shan Medical University

• Shung-Sheng Tsou · Tungs' Taichung Metroharbor Hospital

• Li-Wa Liao · Tungs' Taichung Metroharbor Hospital

• Feng-Chan Shi · Tungs' Taichung Metroharbor Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-05-10

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• Taiwan

Study Locations