Clinical trial NCT05379582: The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography
Official title: The Effect of Early Enteral Nutrition Feeding Process Assisted by Gastrointestinal Ultrasonography in Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Critical Illness
Acute Gastrointestinal Injury
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2022-05-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: mortality
timeFrame: Day28 after enrollment
measure: mortality
timeFrame: Day60 after enrollment
measure: mortality
timeFrame: Day90 after enrollment
measure: Enteral nutrition support days
timeFrame: within first seven days after enteral nutrition initiation
measure: Target-reaching rate through enteral route
timeFrame: within first seven days after enteral nutrition initiation
measure: The application rate of parenteral nutrition（PN）
timeFrame: within first seven days after enteral nutrition initiation
measure: The application rate of prokinetic drugs
timeFrame: within first seven days after enteral nutrition initiation
Secondary outcomes:
measure: Sequential Organ Failure Assessment score
timeFrame: The first day after enrollment.
measure: Acute Physiology and Chronic Health Evaluation score
timeFrame: The first day after enrollment
measure: The average dose of vasoactive drugs
timeFrame: First week of the study
measure: Days of vasoactive drugs
timeFrame: Through study completion, an average of 1 year
measure: Days of mechanical ventilation
timeFrame: Through study completion, an average of 1 year
measure: Days of continuous renal replacement
timeFrame: Through study completion, an average of 1 year
measure: Serum prealbumin in milligram/liter
timeFrame: Day7 after enteral nutrition initiation
measure: Serum prealbumin in milligram/liter
timeFrame: Day14 after enteral nutrition initiation
measure: Serum transferrin in milligram/liter
timeFrame: Day7 after enteral nutrition initiation
measure: Serum transferrin in milligram/liter
timeFrame: Day14 after enteral nutrition initiation
measure: The thickness of diaphragm under ultrasonography in centimeter
timeFrame: Day7 after enteral nutrition initiation
measure: The thickness of diaphragm under ultrasonography in centimeter
timeFrame: Day14 after enteral nutrition initiation
measure: The thickness of diaphragm under ultrasonography in centimeter
timeFrame: Day28 after enteral nutrition initiation
measure: The thickness of quadriceps under ultrasonography in centimeter
timeFrame: Day7 after enteral nutrition initiation
measure: The thickness of quadriceps under ultrasonography in centimeter
timeFrame: Day14 after enteral nutrition initiation
measure: The thickness of quadriceps under ultrasonography in centimeter
timeFrame: Day28 after enteral nutrition initiation
measure: The strength of upper limb according to the Lovett muscle strength scale
timeFrame: Day7 after enteral nutrition initiation
measure: The strength of upper limb according to the Lovett muscle strength scale
timeFrame: Day14 after enteral nutrition initiation
measure: The strength of upper limb according to the Lovett muscle strength scale
timeFrame: Day28 after enteral nutrition initiation
measure: The strength of upper limb according to the Lovett muscle strength scale
timeFrame: Through study completion, an average of 1 year.
measure: The mid-arm circumference in centimeter
timeFrame: Day7 after enteral nutrition initiation
measure: The mid-arm circumference in centimeter
timeFrame: Day14 after enteral nutrition initiation
measure: The mid-arm circumference in centimeter
timeFrame: Day28 after enteral nutrition initiation
measure: The mid-arm circumference in centimeter
timeFrame: Through study completion, an average of 1 year.
measure: The Medical Research Council sum score
timeFrame: Day14 after enteral nutrition initiation
measure: The Medical Research Council sum score
timeFrame: Day28 after enteral nutrition initiation
measure: The Medical Research Council sum score
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
affiliation: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
name: WenKui Yu, Professor
role: PRINCIPAL_INVESTIGATOR
References: