Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

NCT04224883 | Recruiting DMC

• 1 other identifier: DFM-GFC
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastrointestinal Dysfunction; Critical Illness; Nutrition Disorders

Keywords

gastrointestinal function; enteral feeding; critical

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The rate of onset of Gastric residual (%)

  First 5 days after intervention

• Abdominal pressure (mmHg)

  baseline and 5th day

• the rate of new onset pneumonia (%)

  First 5 days after intervention

• The rate(%) of people whom can reaching the caloric goal

  First 5 days after intervention

Other Outcomes (2)

• length of ICU stay (in days)

  up to 12 weeks

• ICU mortality rate (%)

  28 days after intervention

Study Arms (3)

24-hours group

ACTIVE COMPARATOR

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

16-hours group

EXPERIMENTAL

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

intermittent group

EXPERIMENTAL

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

Interventions

Continuously feeding PROCEDURE

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.

Also known as: Continuously-feeding pumped in 24 hours

24-hours group

16-hours feeding PROCEDURE

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.

Also known as: Continuously-feeding pumped in 16 hours

16-hours group

intermittent feeding PROCEDURE

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.

Also known as: intermittent-feeding pumped

intermittent group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510000, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 21963582 RESULT

• 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.

  PMID: 8982828 RESULT

• 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.

  PMID: 8792684 RESULT

• 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.

  PMID: 36266668 DERIVED

MeSH Terms

Conditions

Critical Illness; Nutrition Disorders

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases

Central Study Contacts

Guang Yang

CONTACT

86-20-39318526; yangguang@gzucm.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: June 30, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)