Clinical trial NCT04224883: Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
Official title: Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Dysfunction
Critical Illness
Nutrition Disorders
Keywords: gastrointestinal function
enteral feeding
critical
Lead sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The mean time(hours) that reach to the caloric goal in every group
timeFrame: First 5 days after intervention
Secondary outcomes:
measure: The rate of onset of Gastric residual (%)
timeFrame: First 5 days after intervention
measure: Abdominal pressure (mmHg)
timeFrame: baseline and 5th day
measure: the rate of new onset pneumonia (%)
timeFrame: First 5 days after intervention
measure: The rate(%) of people whom can reaching the caloric goal
timeFrame: First 5 days after intervention
Other outcomes:
measure: length of ICU stay (in days)
timeFrame: up to 12 weeks
measure: ICU mortality rate (%)
timeFrame: 28 days after intervention
Locations:
city: Guangzhou
country: China
facility: 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
state: Guangdong
Study officials:
References:
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.
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.
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.
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.