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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2020-08-31

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 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.

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Detailed Description

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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.

Conditions

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Sepsis Intestinal Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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24-hours group

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.

Group Type ACTIVE_COMPARATOR

24-hours group

Intervention Type 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.

16-hours group

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.

Group Type EXPERIMENTAL

16-hours group

Intervention Type 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.

intermittent group

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.

Group Type EXPERIMENTAL

intermittent group

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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Continuously-feeding pumped in 24 hours group Continuously-feeding pumped in 16 hours group intermittent-feeding pumped group

Eligibility Criteria

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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. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No