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

Critical Illness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379582
• Other study ID #: 2022-050-02
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: April 2022
• Source: Chinese Medical Association
• Contact: Tao Gao, no
• Phone: +86-025-83106666
• Email: ggttt001[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness

Intervention

Other:
• Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
Once the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound.

Locations

Country	Name	City	State
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Medical Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		Day28 after enrollment
Primary	mortality		Day60 after enrollment
Primary	mortality		Day90 after enrollment
Primary	Enteral nutrition support days		within first seven days after enteral nutrition initiation
Primary	Target-reaching rate through enteral route	percentage of participants who reach target calorie through enteral route	within first seven days after enteral nutrition initiation
Primary	The application rate of parenteral nutrition(PN)	percentage of participants who needs parenteral nutrition	within first seven days after enteral nutrition initiation
Primary	The application rate of prokinetic drugs	percentage of participants who needs prokinetic drugs	within first seven days after enteral nutrition initiation
Secondary	Sequential Organ Failure Assessment score	The value ranges from 0 to 24. A higher score means a worse outcome.	The first day after enrollment.
Secondary	Acute Physiology and Chronic Health Evaluation score	The value ranges from 0 to 71. A higher score means a worse outcome.	The first day after enrollment
Secondary	The average dose of vasoactive drugs		First week of the study
Secondary	Days of vasoactive drugs		Through study completion, an average of 1 year
Secondary	Days of mechanical ventilation		Through study completion, an average of 1 year
Secondary	Days of continuous renal replacement		Through study completion, an average of 1 year
Secondary	Serum prealbumin in milligram/liter		Day7 after enteral nutrition initiation
Secondary	Serum prealbumin in milligram/liter		Day14 after enteral nutrition initiation
Secondary	Serum transferrin in milligram/liter		Day7 after enteral nutrition initiation
Secondary	Serum transferrin in milligram/liter		Day14 after enteral nutrition initiation
Secondary	The thickness of diaphragm under ultrasonography in centimeter		Day7 after enteral nutrition initiation
Secondary	The thickness of diaphragm under ultrasonography in centimeter		Day14 after enteral nutrition initiation
Secondary	The thickness of diaphragm under ultrasonography in centimeter		Day28 after enteral nutrition initiation
Secondary	The thickness of quadriceps under ultrasonography in centimeter		Day7 after enteral nutrition initiation
Secondary	The thickness of quadriceps under ultrasonography in centimeter		Day14 after enteral nutrition initiation
Secondary	The thickness of quadriceps under ultrasonography in centimeter		Day28 after enteral nutrition initiation
Secondary	The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Day7 after enteral nutrition initiation
Secondary	The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Day14 after enteral nutrition initiation
Secondary	The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Day28 after enteral nutrition initiation
Secondary	The strength of upper limb according to the Lovett muscle strength scale	The value ranges from 0 to 5. A higher score means a better outcome.	Through study completion, an average of 1 year.
Secondary	The mid-arm circumference in centimeter		Day7 after enteral nutrition initiation
Secondary	The mid-arm circumference in centimeter		Day14 after enteral nutrition initiation
Secondary	The mid-arm circumference in centimeter		Day28 after enteral nutrition initiation
Secondary	The mid-arm circumference in centimeter		Through study completion, an average of 1 year.
Secondary	The Medical Research Council sum score	The value ranges from 0 to 60. A higher score means a better outcome.	Day14 after enteral nutrition initiation
Secondary	The Medical Research Council sum score	The value ranges from 0 to 60. A higher score means a better outcome.	Day28 after enteral nutrition initiation
Secondary	The Medical Research Council sum score	The value ranges from 0 to 60. A higher score means a better outcome.	Through study completion, an average of 1 year