Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

Critical Illness Clinical Trial

— DFM-GFC  

Official title:

Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04224883
• Other study ID #: DFM-GFC
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: June 30, 2025

Study information

• Verified date: March 2024
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Guang Yang
• Phone: 86-20-39318526
• Email: yangguang[@]gzucm.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Septic patients in Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine;

2. APACHE-? 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.

Related Conditions & MeSH terms

• Critical Illness
• Gastrointestinal Dysfunction
• Nutrition Disorders

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & 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. Erratum In: Crit Care — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	length of ICU stay (in days)	length of ICU stay (in days)	up to 12 weeks
Other	ICU mortality rate (%)	ICU mortality rate (%)	28 days after intervention
Primary	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	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
Secondary	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
Secondary	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
Secondary	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