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Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients (DFM-GFC)

Primary Purpose

Gastrointestinal Dysfunction, Critical Illness, Nutrition Disorders

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Continuously feeding
16-hours feeding
intermittent feeding
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Dysfunction focused on measuring gastrointestinal function, enteral feeding, critical

Eligibility Criteria

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

Inclusion Criteria:

  1. Septic patients in Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine;
  2. APACHE-Ⅱ score greater than 15 points;
  3. Signing the informed consent.

Exclusion Criteria:

  1. Fasting patients in the clinical, such as digestive tract perforation, bleeding or postoperative patients with gastrointestinal tract;
  2. Allergic to enteral nutrition preparations;
  3. Don't want to attend the test or not with the healer.

Sites / Locations

  • 2nd Affiliated Hospital of Guangzhou University of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

24-hours group

16-hours group

intermittent group

Arm Description

The critical patients randomized to 24-hours group will be received enteral nutrition preparation by 24 hours of continuously pumping through stomach tube every day. Feeding will be started within 24 hours in admission of ICU. The time of therapy is 5 days.

The critical patients randomized to 16-hours group will be received enteral nutrition preparation by 16 hours of continuously pumping through stomach tube every day. Feeding will be started within 24 hours in admission of ICU. The time of therapy is 5 days.

The critical patients randomized to intermittent group will be received enteral nutrition preparations by four meals every day(08:00,12:00 18:00,22:00), each meal are pumped within 60min or 120min through stomach tube.Feeding will be started within 24 hours in admission of ICU. The time of therapy is 5 days

Outcomes

Primary Outcome Measures

The mean time(hours) that reach to the caloric goal in every group
Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.

Secondary Outcome Measures

The rate of onset of Gastric residual (%)
The definition of gastric residual is that gastric residual volume more than 500 ml. Comparison of rate of gastric residual among three groups.
Abdominal pressure (mmHg)
Abdominal pressure measurement: through the bladder indirect pressure measurement method, first taking the supine position, emptying the bladder urine, secondly pouring 50ml saline into the balloon catheter, to the pubic symphysis as the base point, keeping the piezometric tube be perpendicular to the ground, then abdominal pressure can be obtained indirectly.
the rate of new onset pneumonia (%)
Diagnosis of onset pneumonia is defined as two of the following clinical criteria were required. Fever (>38.3℃) or hypothermia (≤36.0℃), leukocytosis (>10×10E9 cells/liter) or leukopenia (≤4×10E9 cells/liter), purulent tracheal aspirate or sputum. The rate of onset pneumonia be counted in each group.
The rate(%) of people whom can reaching the caloric goal
Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.

Full Information

First Posted
January 8, 2020
Last Updated
May 25, 2022
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04224883
Brief Title
Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
Acronym
DFM-GFC
Official Title
Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The intestine is the most vulnerable target organ in septic patients and is the first to be damaged organ in multiple organ dysfunction syndrome(MODS).Therefore, improving intestinal motility and mucosal barrier function is critical to the treatment of sepsis. Many studies have shown that, early enteral nutrition(EN) in patients with sepsis helps prevent and treat intestinal dysfunction, reducing ICU mortality and length of stay in ICU. However, there is little research on feeding methods. In this study the investigators will compare the outcomes of different feeding methods: continuously-pumped in 24 hours, continuouslypumped in 16 hours and intermittently-pumped through the stomach tube. The aim of this study is to investigate the effects of different feeding methods on intestinal function in septic patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Dysfunction, Critical Illness, Nutrition Disorders
Keywords
gastrointestinal function, enteral feeding, critical

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
24-hours group
Arm Type
Active Comparator
Arm Description
The critical patients randomized to 24-hours group will be received enteral nutrition preparation by 24 hours of continuously pumping through stomach tube every day. Feeding will be started within 24 hours in admission of ICU. The time of therapy is 5 days.
Arm Title
16-hours group
Arm Type
Experimental
Arm Description
The critical patients randomized to 16-hours group will be received enteral nutrition preparation by 16 hours of continuously pumping through stomach tube every day. Feeding will be started within 24 hours in admission of ICU. The time of therapy is 5 days.
Arm Title
intermittent group
Arm Type
Experimental
Arm Description
The critical patients randomized to intermittent group will be received enteral nutrition preparations by four meals every day(08:00,12:00 18:00,22:00), each meal are pumped within 60min or 120min through stomach tube.Feeding will be started within 24 hours in admission of ICU. The time of therapy is 5 days
Intervention Type
Procedure
Intervention Name(s)
Continuously feeding
Other Intervention Name(s)
Continuously-feeding pumped in 24 hours
Intervention Description
Daily amount of feeding were continuously pumped for 24 hours. EN preparation pumping scheme was as follows: The initial pumping speed was average pumping volume of total enteral nutrition in one day, and gastric residual volumes is checked every 4 hours. If it is not tolerable, the speed of the pumping is reduced by half on the original speed. GRV<200mL were considered markers of good tolerance.Feeding intolerance was defined as GRV>200 mL. If GRV>500mL, EN was stopped and reassessed after 4 hours.
Intervention Type
Procedure
Intervention Name(s)
16-hours feeding
Other Intervention Name(s)
Continuously-feeding pumped in 16 hours
Intervention Description
Daily amount of feeding were continuously pumped for 16 hours.EN preparation pumping scheme was as follows: The initial pumping speed was average pumping volume of total enteral nutrition in one day, and gastric residual volumes is checked every 4 hours.If it is not tolerable, the speed of the pumping is reduced by half on the original speed. GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL. If GRV>500mL, EN was stopped and reassessed after 4 hours.
Intervention Type
Procedure
Intervention Name(s)
intermittent feeding
Other Intervention Name(s)
intermittent-feeding pumped
Intervention Description
Daily amount of feeding were divided into four meals, each meal are pumped within 60mins or 120mins through stomach tube. EN preparation pumping scheme was as follows: If the volume of each meal is less than or equal to 250ml(≤250ml), pump in within 60min, if volume is greater than 250ml(>250ml), pump in within 120min and gastric residual volumes is checked before each intermittent feeding. If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed. GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL. If GRV>500mL, EN was stopped and reassessed after 4 hours.
Primary Outcome Measure Information:
Title
The mean time(hours) that reach to the caloric goal in every group
Description
Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.
Time Frame
First 5 days after intervention
Secondary Outcome Measure Information:
Title
The rate of onset of Gastric residual (%)
Description
The definition of gastric residual is that gastric residual volume more than 500 ml. Comparison of rate of gastric residual among three groups.
Time Frame
First 5 days after intervention
Title
Abdominal pressure (mmHg)
Description
Abdominal pressure measurement: through the bladder indirect pressure measurement method, first taking the supine position, emptying the bladder urine, secondly pouring 50ml saline into the balloon catheter, to the pubic symphysis as the base point, keeping the piezometric tube be perpendicular to the ground, then abdominal pressure can be obtained indirectly.
Time Frame
baseline and 5th day
Title
the rate of new onset pneumonia (%)
Description
Diagnosis of onset pneumonia is defined as two of the following clinical criteria were required. Fever (>38.3℃) or hypothermia (≤36.0℃), leukocytosis (>10×10E9 cells/liter) or leukopenia (≤4×10E9 cells/liter), purulent tracheal aspirate or sputum. The rate of onset pneumonia be counted in each group.
Time Frame
First 5 days after intervention
Title
The rate(%) of people whom can reaching the caloric goal
Description
Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.
Time Frame
First 5 days after intervention
Other Pre-specified Outcome Measures:
Title
length of ICU stay (in days)
Description
length of ICU stay (in days)
Time Frame
up to 12 weeks
Title
ICU mortality rate (%)
Description
ICU mortality rate (%)
Time Frame
28 days after intervention

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Septic patients in Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine; APACHE-Ⅱ score greater than 15 points; Signing the informed consent. Exclusion Criteria: Fasting patients in the clinical, such as digestive tract perforation, bleeding or postoperative patients with gastrointestinal tract; Allergic to enteral nutrition preparations; Don't want to attend the test or not with the healer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guang Yang
Phone
86-20-39318526
Email
yangguang@gzucm.edu.cn
Facility Information:
Facility Name
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guang Yang
Phone
86-20-39318526
Email
yg_1918@163.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21963582
Citation
Lagu T, Rothberg MB, Shieh MS, Pekow PS, Steingrub JS, Lindenauer PK. Hospitalizations, costs, and outcomes of severe sepsis in the United States 2003 to 2007. Crit Care Med. 2012 Mar;40(3):754-61. doi: 10.1097/CCM.0b013e318232db65. Erratum In: Crit Care Med. 2012 Oct;40(10):2932.
Results Reference
result
PubMed Identifier
8982828
Citation
Nieuwenhuijzen GA, Deitch EA, Goris RJ. The relationship between gut-derived bacteria and the development of the multiple organ dysfunction syndrome. J Anat. 1996 Dec;189 ( Pt 3)(Pt 3):537-48.
Results Reference
result
PubMed Identifier
8792684
Citation
Pastores SM, Katz DP, Kvetan V. Splanchnic ischemia and gut mucosal injury in sepsis and the multiple organ dysfunction syndrome. Am J Gastroenterol. 1996 Sep;91(9):1697-710.
Results Reference
result
PubMed Identifier
36266668
Citation
Yang G, Deng A, Zheng B, Li J, Yu Y, Ouyang H, Huang X, Chen H. Effect of different feeding methods on gastrointestinal function in critical patients (DFM-GFC): study protocol for a randomized controlled trial. Trials. 2022 Oct 20;23(1):882. doi: 10.1186/s13063-022-06807-7.
Results Reference
derived

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Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

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