Gastrointestinal DysfunctionDFM-GFCNCT04224883
Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
A study testing Continuously feeding, 16-hours feeding and intermittent feeding in people with Gastrointestinal Dysfunction and Critical Illness, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Dysfunction, Critical Illness, Nutrition Disorders
- What is being tested?
- Continuously feeding, 16-hours feeding and intermittent feeding
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510000
Guang Yang, 86-20-39318526, yg_1918@163.com
About this study
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.
- Being tested
- Continuously feeding, 16-hours feeding, intermittent feeding
- Keywords
- gastrointestinal function, enteral feeding, critical
- Medical subject headings
- Critical Illness, Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuously feedingProcedure or surgery
Also called Continuously-feeding pumped in 24 hours
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 feedingProcedure or surgery
Also called Continuously-feeding pumped in 16 hours
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 feedingProcedure or surgery
Also called intermittent-feeding pumped
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.
| Study group | Role | What they receive |
|---|---|---|
| 24-hours group | Active comparator | 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. Receives: Procedure: Continuously feeding |
| 16-hours group | Experimental | 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. Receives: Procedure: 16-hours feeding |
| intermittent group | Experimental | 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 Receives: Procedure: intermittent feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 5 days after intervention
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 5 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jul 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guang Yang, Guangdong Provincial Hospital of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224883
- Sponsor's protocol ID
- DFM-GFC
- Acronym
- DFM-GFC
- Status last verified
- Mar 2024
- First submitted
- 8 Jan 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21963582Nieuwenhuijzen 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.
PubMed 8982828Pastores 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.
PubMed 8792684Yang 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.
PubMed 36266668
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Feeding Method on Gastrointestinal Function of Critical Patients
- ClinicalTrials.gov ID
- NCT04224883
- Acronym / sponsor ID
- DFM-GFC / DFM-GFC
- Keywords
- gastrointestinal function, enteral feeding, critical
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 24-hours group | Active comparator | Procedure: Continuously feedingThe 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. |
| 16-hours group | Experimental | Procedure: 16-hours feedingThe 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. |
| intermittent group | Experimental | Procedure: intermittent feedingThe 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Continuously feedingAlso: Continuously-feeding pumped in 24 hoursDaily 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. | Procedure or surgery | 24-hours group |
| 16-hours feedingAlso: Continuously-feeding pumped in 16 hoursDaily 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. | Procedure or surgery | 16-hours group |
| intermittent feedingAlso: intermittent-feeding pumpedDaily 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. | Procedure or surgery | intermittent group |
Primary outcome
The mean time(hours) that reach to the caloric goal in every group
Time frame: First 5 days after intervention
Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.
4 secondary outcomes
The rate of onset of Gastric residual (%)
Time frame: First 5 days after intervention
Abdominal pressure (mmHg)
Time frame: baseline and 5th day
the rate of new onset pneumonia (%)
Time frame: First 5 days after intervention
The rate(%) of people whom can reaching the caloric goal
Time frame: First 5 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Results publication: PubMed 21963582Lagu 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.
- Results publication: PubMed 8982828Nieuwenhuijzen 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.
- Results publication: PubMed 8792684Pastores 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.
- Derived from this study: PubMed 36266668Yang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuously feeding, 16-hours feeding and intermittent feeding in people with Gastrointestinal Dysfunction and Critical Illness, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guang Yang (86-20-39318526, yangguang@gzucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean time(hours) that reach to the caloric goal in every group (time frame: First 5 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224883, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.