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Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04224883
Acronym
DFM-GFC
Enrollment
90
Registered
2020-01-13
Start date
2020-07-01
Completion date
2025-06-30
Last updated
2024-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Dysfunction, Critical Illness, Nutrition Disorders

Keywords

gastrointestinal function, enteral feeding, critical

Brief 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.

Interventions

PROCEDUREContinuously 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.

PROCEDURE16-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.

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.

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The mean time(hours) that reach to the caloric goal in every groupFirst 5 days after interventionCaloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.

Secondary

MeasureTime frameDescription
The rate of onset of Gastric residual (%)First 5 days after interventionThe definition of gastric residual is that gastric residual volume more than 500 ml. Comparison of rate of gastric residual among three groups.
Abdominal pressure (mmHg)baseline and 5th dayAbdominal 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.
the rate of new onset pneumonia (%)First 5 days after interventionDiagnosis 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.
The rate(%) of people whom can reaching the caloric goalFirst 5 days after interventionCaloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.

Other

MeasureTime frameDescription
length of ICU stay (in days)up to 12 weekslength of ICU stay (in days)
ICU mortality rate (%)28 days after interventionICU mortality rate (%)

Countries

China

Contacts

Primary ContactGuang Yang
yangguang@gzucm.edu.cn86-20-39318526

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026