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

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.

Study Overview

• Status: Recruiting
• Conditions: Critical Illness; Nutrition Disorders; Gastrointestinal Dysfunction
• Intervention / Treatment: Procedure: Continuously feeding; Procedure: 16-hours feeding; Procedure: intermittent feeding

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guang Yang; Phone Number: 86-20-39318526; Email: yangguang@gzucm.edu.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Guang Yang; Phone Number: 86-20-39318526; Email: yg_1918@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 24-hours group; 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.	Procedure: Continuously feeding; 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.; Other Names: Continuously-feeding pumped in 24 hours
Experimental: 16-hours group; 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.	Procedure: 16-hours feeding; 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.; Other Names: Continuously-feeding pumped in 16 hours
Experimental: intermittent group; 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	Procedure: intermittent feeding; 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.; Other Names: intermittent-feeding pumped

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 5 days after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	First 5 days after intervention
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.	baseline and 5th day
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.	First 5 days after intervention
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.	First 5 days after intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
length of ICU stay (in days)	length of ICU stay (in days)	up to 12 weeks
ICU mortality rate (%)	ICU mortality rate (%)	28 days after intervention

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: January 8, 2020
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: enteral feeding; critical; gastrointestinal function
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness; Nutrition Disorders
• Other Study ID Numbers: DFM-GFC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No