SepsisDFM-GFNCT03488940
Effect of Different Feeding Method on Gastrointestinal Function of Septic Patients (DFM-GF Trial)
A study testing 24-hours group, 16-hours group and intermittent group in people with Sepsis and Intestinal Dysfunction, 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
- Sepsis, Intestinal Dysfunction
- What is being tested?
- 24-hours group, 16-hours group and intermittent group
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 31 Aug 2020
- 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;
- Early stage of sepsis (within a week) patients with hemodynamic instability;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510000
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 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.
Read the detailed description
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
- Sepsis, Intestinal Dysfunction
- Being tested
- 24-hours group, 16-hours group, intermittent group
- Keywords
- Sepsis, intestinal dysfunction, enteral feeding
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
24-hours groupDevice
Also called Continuously-feeding pumped in 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.
16-hours groupDevice
Also called Continuously-feeding pumped in 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.
intermittent groupDevice
Also called intermittent-feeding pumped 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.
| Study group | Role | What they receive |
|---|---|---|
| 24-hours group | Active comparator | 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. Receives: Device: 24-hours group |
| 16-hours group | Experimental | 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. Receives: Device: 16-hours group |
| intermittent group | Experimental | 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. Receives: Device: intermittent group |
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 7 days after intervention
Secondary outcomes (5)
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 7 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 7 days
Motilin (MTL) (pg/ml)
the level of plasma MTL
Measured: baseline and 7 days
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 7 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 7 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 posted5 Apr 2018
- Study start1 Jan 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Why it stopped: Subjects were enrolled in other studies about sepsis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- 0 participants (actual)
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
- Investigators
- Jian Li, Study chair, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03488940
- Sponsor's protocol ID
- DFM-GF Trial
- Acronym
- DFM-GF
- Status last verified
- Feb 2020
- First submitted
- 25 May 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing data can be used by retrospective analysis and systematic review about intestinal dysfunction or septic patients starting in January 2022.The data including age, gender, damaged organs, basic disease, APACHE-II score, target calories, the time to reach target calories, gastric residual volume, abdominal pressure (cmH2O), level of plasma motilin(pg/ml), level of plasma intestinal fatty acid binding protein, intestinal dysfunction score, new onset pneumonia, duration of ICU and prognosis.
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 8792684
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Feeding Method on Gastrointestinal Function of Septic Patients (DFM-GF Trial)
- ClinicalTrials.gov ID
- NCT03488940
- Acronym / sponsor ID
- DFM-GF / DFM-GF Trial
- Conditions
- Sepsis, Intestinal Dysfunction
- Keywords
- Sepsis, intestinal dysfunction, enteral feeding
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Subjects were enrolled in other studies about sepsis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guangdong Provincial Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 5 Apr 2018 (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 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.
Detailed description
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.
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 | Device: 24-hours groupThe 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. |
| 16-hours group | Experimental | Device: 16-hours groupThe 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. |
| intermittent group | Experimental | Device: intermittent groupThe 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. |
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 (8 listed)
- Fasting patients in the clinical, such as digestive tract perforation, bleeding or postoperative patients with gastrointestinal tract;
- Allergic to enteral nutrition preparations;
- Early stage of sepsis (within a week) patients with hemodynamic instability;
- Don't want to attend the test or not with the healer.
- 1.Time is less than 7 days in hospital.
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 |
|---|---|---|
| 24-hours groupAlso: Continuously-feeding pumped in 24 hours groupDaily 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. | Device | 24-hours group |
| 16-hours groupAlso: Continuously-feeding pumped in 16 hours groupDaily 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. | Device | 16-hours group |
| intermittent groupAlso: intermittent-feeding pumped groupDaily 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. | Device | intermittent group |
Primary outcome
The mean time(hours) that reach to the caloric goal in every group.
Time frame: First 7 days after intervention
Caloric goals using 25 kcal/kg (ideal body weight) for caloric need calculated by a single nutritionist.
5 secondary outcomes
The rate of onset of Gastric residual (%)
Time frame: First 7 days after intervention
Abdominal pressure (mmHg)
Time frame: baseline and 7 days
Motilin (MTL) (pg/ml)
Time frame: baseline and 7 days
the rate of new onset pneumonia (%)
Time frame: First 7 days after intervention
The rate(%) of people whom can reaching the caloric goal.
Time frame: First 7 days after intervention
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Background: 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.
- Background: 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.
- Background: 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.
- Individual participant dataSharing planned: Yes. Sharing data can be used by retrospective analysis and systematic review about intestinal dysfunction or septic patients starting in January 2022.The data including age, gender, damaged organs, basic disease, APACHE-II score, target calories, the time to reach target calories, gastric residual volume, abdominal pressure (cmH2O), level of plasma motilin(pg/ml), level of plasma intestinal fatty acid binding protein, intestinal dysfunction score, new onset pneumonia, duration of ICU and prognosis.
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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.
Jian Li study chair
2nd Affiliated Hospital of Guangzhou University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 24-hours group, 16-hours group and intermittent group in people with Sepsis and Intestinal Dysfunction, 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 8 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: withdrawn, as of the sponsor's last update on 11 Feb 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 7 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 NCT03488940, which also lists 3 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 11 Feb 2020.