The Effect of Standardized Enteral Nutrition on Critically Ill Patients

NCT02976155 | Completed DMC

• 1 other identifier: 87783921
• Study Type: interventional
• Target: 439
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to evaluate whether a standard enteral nutrition protocol can improve the efficiency in achieving nutritional goals and improve prognosis in critically ill patients.

Conditions

Critically Ill

Keywords

critically ill, intensive care, enteral nutrition

Outcome Measures

Primary Outcomes (5)

• The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition

  7 days after ICU admission

• The time from hospital admission to the begain Enteral nutrition.

  7 days after ICU admission

• The time from hospital admission to achieve the target calorie.

  7 days after ICU admission

• The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition

  7 days after ICU admission

• The proportion of patients receiving Enteral plus supplement parenteral in patients receiving any type of nutrition

  7 days after ICU admission

Secondary Outcomes (6)

• ICU mortality.

  From date of the ICU admission until discharge form ICU,assessed up to 12 months

• Hospital mortality.

  From date of the ICU admission until discharge form hospital,assessed up to 12 months

• ICU length of stay

  From date of the ICU admission until discharge form ICU,assessed up to 12 months

• Duration of mechanical ventilation.

  From date of the initiation of mechanical ventilation until weaning,assessed up to 12 months

• ICU fee.

  From date of the ICU admission until discharge form ICU,assessed up to 12 months

Study Arms (2)

Pre-intervention

NO INTERVENTION

enteral nutrition according routine practice

Post-intervention

EXPERIMENTAL

The intervention in this arm is the application of a standard enteral nutrition protocol

Other: A standard enteral nutrition protocol

Interventions

A standard enteral nutrition protocol OTHER

Patients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention).

Post-intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Critically ill patients who is expected the length of ICU stay for more than 3 days

You may not qualify if:

• Patients who can obtain enough calorie through independent oral feeding. Patients aged less than 18 years. Patients who are pregnant or breastfeeding. Patients who are burned. Patients with malignant tumor terminal stages of diseases

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Department of Emergency Medicine, People's Hospital of Shaoxing, Shaoxing, China.: collaborator
• Department of Emergency Medicine, Wenzhou Central Hospital, Wenzhou, China.: collaborator
• Department of Emergency Medicine, The First People's Hospital of Hangzhou, Hangzhou, China.: collaborator
• Department of Emergency Medicine, The First Affiliated Hospital of Wenzhou Medical University, Wenzhou, China.: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Emergency Department, The First People's Hospital of Huzhou, Huzhou, China.: collaborator
• Department of Critical Care Medicine, The First People's Hospital of Xiaoshan District, Hangzhou, China.: collaborator
• Emergency Department, Jinhua Hospital of Zhejiang University, Jinhua, China.: collaborator
• Department of Critical Care Medicine, The First People's Hospital of Fuyang district, Hangzhou, China.: collaborator
• Department of Critical Care Medicine, Beilun District People's Hospital, Ningbo, China.: collaborator
• The Affiliated Hospital of Hangzhou Normal University: collaborator
• The Third Affiliated Hospital of Wenzhou Medical University: collaborator
• Yuyao People's Hospital: collaborator
• Department of Emergency Intensive Care Unit, The Second Hospital of Jiaxing, No 1518, Huanchengbei Rd, Jiaxing, China.: collaborator

Study Sites (1)

The second affiliated hospital of Zhejiang university, school of medicine.

Hangzhou, Zhejiang, 310009, China

Location

Related Publications (1)

• Jiang L, Huang X, Wu C, Tang J, Li Q, Feng X, He T, Wang Z, Gao J, Ruan Z, Hong W, Lai D, Zhao F, Huang Z, Lu Z, Tang W, Zhu L, Zhang B, Wang Z, Shen X, Lai J, Ji Z, Fu K, Hong Y, Dai J, Hong G, Xu W, Wang Y, Xie Y, Chen Y, Zhu X, Ding G, Gu L, Zhang M. The effects of an enteral nutrition feeding protocol on critically ill patients: A prospective multi-center, before-after study. J Crit Care. 2020 Apr;56:249-256. doi: 10.1016/j.jcrc.2020.01.018. Epub 2020 Jan 17.

  PMID: 31986368 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before-after study model

Study Record Dates

• First Submitted: November 15, 2016
• First Posted: November 29, 2016
• Study Start: October 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 15, 2021

Record last verified: 2018-09

Locations

CN (1)