Effect of Different Feeding Method on Gastrointestinal Function of Septic Patients (DFM-GF Trial)

NCT03488940 | Withdrawn DMC

• 1 other identifier: DFM-GF Trial
• Study Type: interventional
• Target: N/A
• 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 we will compare the outcomes of different feeding methods: continuously-pumped in 24 hours, continuously-pumped 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

Sepsis; Intestinal Dysfunction

Keywords

Sepsis; intestinal dysfunction; enteral feeding

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 7 days after intervention

Secondary Outcomes (5)

• The rate of onset of Gastric residual (%)

  First 7 days after intervention

• Abdominal pressure (mmHg)

  baseline and 7 days

• Motilin (MTL) (pg/ml)

  baseline and 7 days

• the rate of new onset pneumonia (%)

  First 7 days after intervention

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

  First 7 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 septic 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 7 days.

Device: 24-hours group

16-hours group

EXPERIMENTAL

The septic 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 7 days.

Device: 16-hours group

intermittent group

EXPERIMENTAL

The septic 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 60mins through stomach tube. Feeding will be started within 24 hours in admission of ICU. The time of therapy is 7 days.

Device: intermittent group

Interventions

24-hours group DEVICE

Daily amount of feeding were continuously pumped for 24 hours. Enteral nutrition preparations pumping scheme: the initial pumping speed is 40ml/h, and gastric residual volumes(GRV) is checked every 4 hours. 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. Enteral nutrition preparation are Enteral Nutritional Suspension(TPF-FOS) which were producted by ABBOTT LABORATORIES B.V.. The feeding pump are Infusion pump P-600 which were producted by Atom Medical Corporation.

Also known as: Continuously-feeding pumped in 24 hours group

24-hours group

16-hours group DEVICE

Daily amount of feeding were continuously pumped for 24 hours.Enteral nutrition preparations pumping scheme: the initial pumping speed is 40ml/h, and gastric residual volumes is checked every 4 hours. 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. Enteral nutrition preparation are Enteral Nutritional Suspension(TPF-FOS) which were producted by ABBOTT LABORATORIES B.V.. The feeding pump are Infusion pump P-600 which were producted by Atom Medical Corporation.

Also known as: Continuously-feeding pumped in 16 hours group

16-hours group

intermittent group DEVICE

Daily amount of feeding were divided into four meals, each meal are pumped within 60mins through stomach tube. Enteral nutrition preparations pumping scheme: the initial pumping speed is 200ml/h, 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. Enteral nutrition preparation are Enteral Nutritional Suspension(TPF-FOS) which were producted by ABBOTT LABORATORIES B.V.. The feeding pump are Infusion pump P-600 which were producted by Atom Medical Corporation.

Also known as: intermittent-feeding pumped group

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;
• Early stage of sepsis (within a week) patients with hemodynamic instability;
• Don't want to attend the test or not with the healer.
• Fall Off Criteria:
• Time is less than 7 days in hospital.
• Suspension or Termination Criteria:
• The patients can't tolerate enteral nutrition preparations.

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

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jian Li

  2nd Affiliated Hospital of Guangzhou University of Chinese Medicine

  STUDY CHAIR

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: May 25, 2017
• First Posted: April 5, 2018
• Study Start: January 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: August 31, 2020
• Last Updated: February 11, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Three years after the end of the study (starting in January 2022)
• Access Criteria: Sharing data can be used by retrospective analysis, mechanism research and systematic reviews about intestinal dysfunction or septic patients. The researchers should be clinicians or medical researchers of respirology, intensive care medicine or gastroenterology.

Locations

CN (1)