Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
NCT ID: NCT04224883
Last Updated: 2024-03-05
Study Results
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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RECRUITING
NA
90 participants
INTERVENTIONAL
2020-07-01
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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24-hours group
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.
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 group
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.
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 group
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
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. APACHE-Ⅱ score greater than 15 points;
3. Signing the informed consent.
Exclusion Criteria
2. Allergic to enteral nutrition preparations;
3. Don't want to attend the test or not with the healer.
ALL
No
Sponsors
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Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Responsible Party
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Guang Yang
Director
Locations
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2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
Other Identifiers
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DFM-GFC
Identifier Type: -
Identifier Source: org_study_id
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