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

Sepsis Clinical Trial

— DFM-GF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03488940
• Other study ID #: DFM-GF Trial
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: February 2020
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: n/a
• 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 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.

Description:

Sepsis is the major cause of death in intensive care unit(ICU). According to the latest literature statistics in 2012, the mortality of sepsis was growing at 2% a year in the United States, and the average hospitalization costs of septic patients was more than $20000. Sepsis has become one of the big challenges to doctors in ICU all over the world. Previous studies found that intestinal dysfunction may be the main promoter and stimulating factor of systemic inflammatory response syndrome(SIRS), which plays an important role of in the development of sepsis to multiple organ dysfunction syndrome(MODS). But at present there is no effective treatment of intestinal dysfunction. Nutrient intake is considered part of the resuscitation of critical patients. Enteral feedings are considered standard treatment of the critically ill patients. A number of study have found enteral feedings could cure intestine dysfunction through improving circulation perfusion and oxygen delivery, maintaining intestinal mucosal barrier, reconstructing intestinal continuity and adjusting internal environment. Recent clinical researches and guidelines pointed out the importance of early enteral nutrition. However, guidelines made no mention of how to carry on the feeding method in severe patients, and related research is few.The current research mostly thinks, enteral nutrition preparations continuously pumped by stomach tube is a more accepted way.The researches cited by the guideline showed that the continuous feeding was better than that of intermittent feeding. But 24 hours of continuous pumping nutrition preparation will not only cause continuous stimulation to the intestinal mucosa, but also lead to gastrointestinal tract have not rest time. Some previous studies found intermittent feedings were better than continuous feedings to critical patients. So，was intermittent feeding really better? Therefore this research will compare the results of different feeding methods of EN: continuously-pumped in 24 hours, continuously-pumped in 16 hours and intermittently-pumped through the stomach tube. Then observe the effects of different feeding methods on intestinal function in septic patients so as to offer a more suitable EN feeding method for septic patients.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 31, 2020
• Est. primary completion date: June 30, 2020
• 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. Early stage of sepsis (within a week) patients with hemodynamic instability;

4. Don't want to attend the test or not with the healer.

Fall Off Criteria:

1.Time is less than 7 days in hospital.

Suspension or Termination Criteria:

1.The patients can't tolerate enteral nutrition preparations.

Related Conditions & MeSH terms

• Intestinal Dysfunction
• Sepsis

Intervention

Device:
• 24-hours group
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.
• 16-hours group
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.
• intermittent group
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.

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 Med. 2012 Oct;40(10):2932. — 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):537-48. Review. — 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. Review. — 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 7 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 7 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 7 days
Secondary	Motilin (MTL) (pg/ml)	the level of plasma MTL	baseline and 7 days
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 7 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 7 days after intervention