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NCT Number: NCT05379582

The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography

In critical ill patients, feeding protocol is one of the important factor which determines the successful implementation of enteral nutrition（EN）. Acute gastrointestinal injury(AGI) affects feeding tolerance, which greatly determines the successful implementation of feeding protocol. In our previously study, we found that transabdominal intestinal sonography is helpful to diagnosis AGI. Thus in this study ,we apply transabdominal gastrointestinal sonography to feeding protocol, to assess the feasibility of gastrointestinal sonography assisted enteral nutrition and its impact on critical ill patients.

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Key information

Conditions

Critical Illness Acute Gastrointestinal Injury 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

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210000, China

About this study

Patients meeting inclusion and exclusion criteria were randomly assigned to the intervention group and control group. During the first week of initiation of nutrition, enteral nutrition was conducted according to different procedures to observe the impact of different feeding procedures on clinical indicators

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • The age is not less than 18 years
  • within 24 hours after entering ICU
  • Acute Physiology and Chronic Health Evaluation II (APACHE II) score > 8
  • the estimated length of stay in ICU is more than 3 days
  • informed consent

Exclusion criteria

  • The normal anatomy of stomach, small intestine or the right colon was significantly changed (Gastrectomy, esophagectomy, pancreaticoduodenectomy, gastrointestinal bypass surgery, the presence of short bowel syndrome,etc.)
  • Uncontrolled gastrointestinal bleeding
  • Uncontrolled intestinal obstruction
  • Uncontrolled mesenteric vascular disease
  • Pregnancy
  • breastfeeding
  • Received enteral nutrition or parenteral nutrition within 24 hours prior to ICU admission
  • Predict death within 48 hours after ICU admission
  • Enrolled in this study before.

Treatment and study plan

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

Other

Once the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound.

Primary outcomes

  1. Target-reaching rate through enteral route

    Time frame: Within first week

    percentage of participants who reach target calorie through enteral route

Secondary outcomes

  1. The incidence of feeding intolerance

    Time frame: Within first week

  2. The application of parenteral nutrition

    Time frame: Within first week

  3. The application of prokinetic drugs

    Time frame: Within first week

  4. The ues of vasoactive drugs

    Time frame: Within first week

  5. Mechanical ventilation

    Time frame: Within first week

  6. Continuous renal replacement

    Time frame: Within first week

  7. The CRP level

    Time frame: Day0/1/3/5/7

  8. Mortality

    Time frame: Day28、Day60、during hospitalization

  9. ICU length of stay

    Time frame: During ICU stay

  10. Length of hospital stay

    Time frame: During hospital stay

  11. Platelet count

    Time frame: Day0,1,3,5,7

  12. Total bilirubin

    Time frame: Day0,1,3,5,7

  13. Serum creatinine

    Time frame: Day0,1,3,5,7

Sponsors and collaborators

Lead sponsor

Chinese Medical Association

Network

Registry information

Official study title

The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 18, 2022
Registry last updated
Jan 28, 2026

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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