Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

Conditions
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Gastrointestinal Dysfunction, Critical Illness, Nutrition Disorders

Intervention / Treatment
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* Procedure: Continuously feeding
* Procedure: 16-hours feeding
* Procedure: intermittent feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 24-hours group<br>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<br>* 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.<br>* Other names: Continuously-feeding pumped in 24 hours;|
| Experimental: 16-hours group<br>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<br>* 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.<br>* Other names: Continuously-feeding pumped in 16 hours;|
| Experimental: intermittent group<br>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<br>* 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.<br>* Other names: intermittent-feeding pumped;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastrointestinal function, enteral feeding, critical