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NCT Number: NCT02976155

The Effect of Standardized Enteral Nutrition on Critically Ill Patients

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.

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Key information

Conditions

Critically Ill Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Hangzhou, Zhejiang, 310009, China

About this study

As investigators all know, the nutrition status in critically ill patients is associated with the prognosis of these patients. And it has been confirmed that early enteral nutrition results in better outcome. However,some epidemiological investigation reported that in most intensive care unit, the phenomenon of delayed feeding or under feeding are not uncommon. In 2007, a study reported that the percentage of early enteral nutrition within 48h is 64%, based on mechanical ventilated patients in 208 intensive care unit nationally. Other study indicated that the calorie supported by the enteral nutrition only constitute 50% of the target calorie. Several studies have showed that the application of a standard enteral nutrition protocol could result in an improvement in the delivery of enteral feedings to patients. However, there is no such study in China.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

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).

Primary outcomes

  1. The proportion of patients receiving enteral nutrition in patients receiving any type of nutrition

    Time frame: 7 days after ICU admission

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

    Time frame: 7 days after ICU admission

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

    Time frame: 7 days after ICU admission

  4. The proportion of patients receiving parenteral nutrition in patients receiving any type of nutrition

    Time frame: 7 days after ICU admission

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

    Time frame: 7 days after ICU admission

Secondary outcomes

  1. ICU mortality.

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

  2. Hospital mortality.

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

  3. ICU length of stay

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

  4. Duration of mechanical ventilation.

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

  5. ICU fee.

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

  6. The incidence of complications(Diarrhea , abdominal distension, nausea and vomiting.)

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

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

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

Registry information

Official study title

The Effect of a Standard Enteral Nutrition Protocol on Critically Ill Patients: a Multiple-center, Prospective, Before-after Study

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 29, 2016
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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