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

Primary Purpose

Critical Illness, Acute Gastrointestinal Injury

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
Sponsored by
Chinese Medical Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Critical Illness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nanjing Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control group

intervention group

Arm Description

Implement nutrition therapy according to existing feeding procedures

Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound

Outcomes

Primary Outcome Measures

mortality
mortality
mortality
Enteral nutrition support days
Target-reaching rate through enteral route
percentage of participants who reach target calorie through enteral route
The application rate of parenteral nutrition（PN）
percentage of participants who needs parenteral nutrition
The application rate of prokinetic drugs
percentage of participants who needs prokinetic drugs

Secondary Outcome Measures

Sequential Organ Failure Assessment score
The value ranges from 0 to 24. A higher score means a worse outcome.
Acute Physiology and Chronic Health Evaluation score
The value ranges from 0 to 71. A higher score means a worse outcome.
The average dose of vasoactive drugs
Days of vasoactive drugs
Days of mechanical ventilation
Days of continuous renal replacement
Serum prealbumin in milligram/liter
Serum prealbumin in milligram/liter
Serum transferrin in milligram/liter
Serum transferrin in milligram/liter
The thickness of diaphragm under ultrasonography in centimeter
The thickness of diaphragm under ultrasonography in centimeter
The thickness of diaphragm under ultrasonography in centimeter
The thickness of quadriceps under ultrasonography in centimeter
The thickness of quadriceps under ultrasonography in centimeter
The thickness of quadriceps under ultrasonography in centimeter
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.
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.
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.
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.
The mid-arm circumference in centimeter
The mid-arm circumference in centimeter
The mid-arm circumference in centimeter
The mid-arm circumference in centimeter
The Medical Research Council sum score
The value ranges from 0 to 60. A higher score means a better outcome.
The Medical Research Council sum score
The value ranges from 0 to 60. A higher score means a better outcome.
The Medical Research Council sum score
The value ranges from 0 to 60. A higher score means a better outcome.

Full Information

First Posted
April 28, 2022
Last Updated
May 13, 2022
Sponsor
Chinese Medical Association
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1. Study Identification

Unique Protocol Identification Number
NCT05379582
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Anticipated)
Study Completion Date
June 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chinese Medical Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness, Acute Gastrointestinal Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Implement nutrition therapy according to existing feeding procedures
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
Intervention Type
Other
Intervention Name(s)
Implement nutrition therapy according a procedure assisted by gastrointestinal ultrasound
Intervention Description
Once the critical ill patients is stable, enteral nutrition was initiated following a procedure assisted by gastrointestinal ultrasound.
Primary Outcome Measure Information:
Title
mortality
Time Frame
Day28 after enrollment
Title
mortality
Time Frame
Day60 after enrollment
Title
mortality
Time Frame
Day90 after enrollment
Title
Enteral nutrition support days
Time Frame
within first seven days after enteral nutrition initiation
Title
Target-reaching rate through enteral route
Description
percentage of participants who reach target calorie through enteral route
Time Frame
within first seven days after enteral nutrition initiation
Title
The application rate of parenteral nutrition（PN）
Description
percentage of participants who needs parenteral nutrition
Time Frame
within first seven days after enteral nutrition initiation
Title
The application rate of prokinetic drugs
Description
percentage of participants who needs prokinetic drugs
Time Frame
within first seven days after enteral nutrition initiation
Secondary Outcome Measure Information:
Title
Sequential Organ Failure Assessment score
Description
The value ranges from 0 to 24. A higher score means a worse outcome.
Time Frame
The first day after enrollment.
Title
Acute Physiology and Chronic Health Evaluation score
Description
The value ranges from 0 to 71. A higher score means a worse outcome.
Time Frame
The first day after enrollment
Title
The average dose of vasoactive drugs
Time Frame
First week of the study
Title
Days of vasoactive drugs
Time Frame
Through study completion, an average of 1 year
Title
Days of mechanical ventilation
Time Frame
Through study completion, an average of 1 year
Title
Days of continuous renal replacement
Time Frame
Through study completion, an average of 1 year
Title
Serum prealbumin in milligram/liter
Time Frame
Day7 after enteral nutrition initiation
Title
Serum prealbumin in milligram/liter
Time Frame
Day14 after enteral nutrition initiation
Title
Serum transferrin in milligram/liter
Time Frame
Day7 after enteral nutrition initiation
Title
Serum transferrin in milligram/liter
Time Frame
Day14 after enteral nutrition initiation
Title
The thickness of diaphragm under ultrasonography in centimeter
Time Frame
Day7 after enteral nutrition initiation
Title
The thickness of diaphragm under ultrasonography in centimeter
Time Frame
Day14 after enteral nutrition initiation
Title
The thickness of diaphragm under ultrasonography in centimeter
Time Frame
Day28 after enteral nutrition initiation
Title
The thickness of quadriceps under ultrasonography in centimeter
Time Frame
Day7 after enteral nutrition initiation
Title
The thickness of quadriceps under ultrasonography in centimeter
Time Frame
Day14 after enteral nutrition initiation
Title
The thickness of quadriceps under ultrasonography in centimeter
Time Frame
Day28 after enteral nutrition initiation
Title
The strength of upper limb according to the Lovett muscle strength scale
Description
The value ranges from 0 to 5. A higher score means a better outcome.
Time Frame
Day7 after enteral nutrition initiation
Title
The strength of upper limb according to the Lovett muscle strength scale
Description
The value ranges from 0 to 5. A higher score means a better outcome.
Time Frame
Day14 after enteral nutrition initiation
Title
The strength of upper limb according to the Lovett muscle strength scale
Description
The value ranges from 0 to 5. A higher score means a better outcome.
Time Frame
Day28 after enteral nutrition initiation
Title
The strength of upper limb according to the Lovett muscle strength scale
Description
The value ranges from 0 to 5. A higher score means a better outcome.
Time Frame
Through study completion, an average of 1 year.
Title
The mid-arm circumference in centimeter
Time Frame
Day7 after enteral nutrition initiation
Title
The mid-arm circumference in centimeter
Time Frame
Day14 after enteral nutrition initiation
Title
The mid-arm circumference in centimeter
Time Frame
Day28 after enteral nutrition initiation
Title
The mid-arm circumference in centimeter
Time Frame
Through study completion, an average of 1 year.
Title
The Medical Research Council sum score
Description
The value ranges from 0 to 60. A higher score means a better outcome.
Time Frame
Day14 after enteral nutrition initiation
Title
The Medical Research Council sum score
Description
The value ranges from 0 to 60. A higher score means a better outcome.
Time Frame
Day28 after enteral nutrition initiation
Title
The Medical Research Council sum score
Description
The value ranges from 0 to 60. A higher score means a better outcome.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tao Gao, no
Phone
+86-025-83106666
Email
ggttt001@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
WenKui Yu, Professor
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tao Gao, no
Phone
86-025-83106666
Email
ggttt001@163.com

12. IPD Sharing Statement

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

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