Nutrition, EnteralNCT03017079
A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
A study testing semi-solid agent with standard enteral feeding and standard enteral feeding in people with Nutrition, Enteral, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Malnutrition and underfeeding are major challenges in caring for critically ill patients. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an… Read more about this study
- Who is it for?
- Ages 14 to 90 years
- Conditions the study is for
- Nutrition, Enteral
- What is being tested?
- semi-solid agent with standard enteral feeding and standard enteral feeding
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2016to 1 Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 14 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- (1)14 years and older, who received EN for more than 72 hours, were eligible for inclusion (2) all patients started on EN by nasogastric tube
Who cannot join
- received EN <72 hours
- received EN prior to ICU admission
- had acute pulmonary infection
- had history of Gastrointestinal surgery
- had contraindications of EN, such as intestinal obstruction (mechanical or paralytic ileus).
Trial locations and contacts
1 site in 1 country.
China1 site
Second affiliated hospital, Zhejiang university school of medicine
Hangzhou, Zhejiang, 310052
About this study
Malnutrition and underfeeding are major challenges in caring for critically ill patients. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the length of stay (LOS)-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous. Some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).
Read the detailed description
Enteral nutrition (EN) therapy is an essential part in critically ill patients，and can be administered on a continuous or intermittent, but there were no consensus on which should be adopted. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the LOS-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous.
Recently, some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. In dementia or Parkinson's patients, one study showed that high-viscosity liquid meal could decrease the incidence of aspiration, compared with the thin liquid, but the study about the viscosity of nutrition was little and the sample size was small.
In this study, the primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).
- Conditions
- Nutrition, Enteral
- Being tested
- semi-solid agent with standard enteral feeding, standard enteral feeding
- Keywords
- Semi-solidification, caloric debt, enteral nutrition, critical illness
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-solid agent with standard enteral feedingDietary supplement
Also called semi-solidification of nutrient
after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes
standard enteral feedingOther
Also called standard enteral nutrition
Intermittent enteral feeding is applied less than 60 minutes
| Study group | Role | What they receive |
|---|---|---|
| semi-solidification with nutrient | Experimental | semi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins.
Intervention: Other: bolus Intermittent enteral feeding Receives: Dietary Supplement: semi-solid agent with standard enteral feeding |
| Standard enteral nutrition | Placebo comparator | After infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins.
Intervention: Other: Standard enteral feeding Receives: Other: standard enteral feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Ratio of the Enteral Nutrition
the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate
Measured: 3 days after receiving enteral nutrition
Secondary outcomes (5)
the Patient of Feeding Intolerance（FI）
the definition of FI was included one of the conditions:diarrhea, vomiting, regurgitation, obvious bowel distension and GRV>200mL.
Due to the small sample size, only the number of patients who occurred was recorded.
Measured: 3 days
the Patients With Lung Infection
patient contain the following three conditions:
1.Sputum volume increased or Sputum properties change;2.CT Scan-Chest suggest that there was lung infection; 3.CRP and / or PCT increased
Measured: 7 days
30-days Mortality
dead within 30 days in ICU
Measured: 30 days
the Glycemic Variability(GV)
Divided into three grades:I:GV less than 4mmol/24h; II 4-6mmol/24h;III more than 6mmol/24h
Measured: 3 days
Length of Hospital Stay (LOS)
every participators stayed in hospital
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study start1 Jun 2016
- Primary completion1 Mar 2017
- Study completion1 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Nutrition, EnteralStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Man Huang, Ph.D, Second Affiliated Hospital, Zhejiang University, School of Medicine
- Investigators
- man huang, phD, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017079
- Sponsor's protocol ID
- lukongmiao123
- Status last verified
- Oct 2021
- First submitted
- 6 Jan 2017
- Last updated
- 2 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7.
PubMed 24714361Evans DC, Forbes R, Jones C, Cotterman R, Njoku C, Thongrong C, Tulman D, Bergese SD, Thomas S, Papadimos TJ, Stawicki SP. Continuous versus bolus tube feeds: Does the modality affect glycemic variability, tube feeding volume, caloric intake, or insulin utilization? Int J Crit Illn Inj Sci. 2016 Jan-Mar;6(1):9-15. doi: 10.4103/2229-5151.177357.
PubMed 27051616MacLeod JB, Lefton J, Houghton D, Roland C, Doherty J, Cohn SM, Barquist ES. Prospective randomized control trial of intermittent versus continuous gastric feeds for critically ill trauma patients. J Trauma. 2007 Jul;63(1):57-61. doi: 10.1097/01.ta.0000249294.58703.11.
PubMed 17622869Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society of Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med. 2016 Feb;44(2):390-438. doi: 10.1097/CCM.0000000000001525. No abstract available.
PubMed 26771786Logemann JA, Gensler G, Robbins J, Lindblad AS, Brandt D, Hind JA, Kosek S, Dikeman K, Kazandjian M, Gramigna GD, Lundy D, McGarvey-Toler S, Miller Gardner PJ. A randomized study of three interventions for aspiration of thin liquids in patients with dementia or Parkinson's disease. J Speech Lang Hear Res. 2008 Feb;51(1):173-83. doi: 10.1044/1092-4388(2008/013).
PubMed 18230864Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.
PubMed 22242022Hayat JO, Gabieta-Somnez S, Yazaki E, Kang JY, Woodcock A, Dettmar P, Mabary J, Knowles CH, Sifrim D. Pepsin in saliva for the diagnosis of gastro-oesophageal reflux disease. Gut. 2015 Mar;64(3):373-80. doi: 10.1136/gutjnl-2014-307049. Epub 2014 May 7.
PubMed 24812000Lu K, Zeng F, Li Y, Chen C, Huang M. A more physiological feeding process in ICU: Intermittent infusion with semi-solid nutrients (CONSORT-compliant). Medicine (Baltimore). 2018 Sep;97(36):e12173. doi: 10.1097/MD.0000000000012173.
PubMed 30200118
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A More Physiological Feeding Process in ICU:the Intermittent Infusion With Semi-solidification of Nutrients
- ClinicalTrials.gov ID
- NCT03017079
- Acronym / sponsor ID
- lukongmiao123
- Conditions
- Nutrition, Enteral
- Keywords
- Semi-solidification, caloric debt, enteral nutrition, critical illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Mar 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 11 Jan 2017 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Malnutrition and underfeeding are major challenges in caring for critically ill patients. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the length of stay (LOS)-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous. Some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. The primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).
Detailed description
Enteral nutrition (EN) therapy is an essential part in critically ill patients，and can be administered on a continuous or intermittent, but there were no consensus on which should be adopted. Continuous feeding were thought to be better tolerated by patients with the limited absorptive gut surface area or gastrointestinal dysfunction, but associated with more tube clogging and required the patient to be attached to an infusion pump for significant periods of time. Intermittent infusion resembled more physiological feeding process, which allowed greater patient mobility and might reach goal enteral calories earlier, and the latter were considered to effectively decrease the LOS-in-hospital and mortality. However, it also had some previous study found that intermittent infusion had more complications, such as diarrhea, regurgitation than continuous.
Recently, some study found that it was an efficient way to prevent aspiration and reflux by increasing the enteral nutrient solution viscosity and improve bolus intermittent feeding intolerance. In dementia or Parkinson's patients, one study showed that high-viscosity liquid meal could decrease the incidence of aspiration, compared with the thin liquid, but the study about the viscosity of nutrition was little and the sample size was small.
In this study, the primary goal of this was to study whether receiving semi-solidification of nutrients could increase the percent prescribed calories received by improving the feeding intolerance, and secondary goal was to observing the effect of semi-solid nutrient to the LOS of ICU and in-hospital, lung infection, 30-days mortality and the glycemic variability (GV).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| semi-solidification with nutrient | Experimental | Dietary Supplement: semi-solid agent with standard enteral feedingsemi-solidification with nutrient:after infusion of semi-solid agent, enteral nutrition is applied less than 60 mins. Intervention: Other: bolus Intermittent enteral feeding |
| Standard enteral nutrition | Placebo comparator | Other: standard enteral feedingAfter infusion of Sterile Water for Injection,bolus Intermittent enteral feeding via the nasogastric tube is applied less than 60 mins. Intervention: Other: Standard enteral feeding |
Who may qualify
- Ages
- 14 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- (1)14 years and older, who received EN for more than 72 hours, were eligible for inclusion (2) all patients started on EN by nasogastric tube
Key exclusion criteria (5 listed)
- received EN <72 hours
- received EN prior to ICU admission
- had acute pulmonary infection
- had history of Gastrointestinal surgery
- had contraindications of EN, such as intestinal obstruction (mechanical or paralytic ileus).
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 |
|---|---|---|
| semi-solid agent with standard enteral feedingAlso: semi-solidification of nutrientafter infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 minutes | Dietary supplement | semi-solidification with nutrient |
| standard enteral feedingAlso: standard enteral nutritionIntermittent enteral feeding is applied less than 60 minutes | Other | Standard enteral nutrition |
Primary outcome
the Ratio of the Enteral Nutrition
Time frame: 3 days after receiving enteral nutrition
the ratio of the enteral nutrition=administered volume of enteral nutrition / prescribed volume of nutrition X 100%; This ratio fluctuates between 0 and 100%, and the higher the ratio, the higher the execution rate
5 secondary outcomes
the Patient of Feeding Intolerance（FI）
Time frame: 3 days
the Patients With Lung Infection
Time frame: 7 days
30-days Mortality
Time frame: 30 days
the Glycemic Variability(GV)
Time frame: 3 days
Length of Hospital Stay (LOS)
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24714361Peev MP, Yeh DD, Quraishi SA, Osler P, Chang Y, Gillis E, Albano CE, Darak S, Velmahos GC. Causes and consequences of interrupted enteral nutrition: a prospective observational study in critically ill surgical patients. JPEN J Parenter Enteral Nutr. 2015 Jan;39(1):21-7. doi: 10.1177/0148607114526887. Epub 2014 Apr 7.
- Results publication: PubMed 27051616Evans DC, Forbes R, Jones C, Cotterman R, Njoku C, Thongrong C, Tulman D, Bergese SD, Thomas S, Papadimos TJ, Stawicki SP. Continuous versus bolus tube feeds: Does the modality affect glycemic variability, tube feeding volume, caloric intake, or insulin utilization? Int J Crit Illn Inj Sci. 2016 Jan-Mar;6(1):9-15. doi: 10.4103/2229-5151.177357.
- Results publication: PubMed 17622869MacLeod JB, Lefton J, Houghton D, Roland C, Doherty J, Cohn SM, Barquist ES. Prospective randomized control trial of intermittent versus continuous gastric feeds for critically ill trauma patients. J Trauma. 2007 Jul;63(1):57-61. doi: 10.1097/01.ta.0000249294.58703.11.
- Results publication: PubMed 26771786Taylor BE, McClave SA, Martindale RG, Warren MM, Johnson DR, Braunschweig C, McCarthy MS, Davanos E, Rice TW, Cresci GA, Gervasio JM, Sacks GS, Roberts PR, Compher C; Society of Critical Care Medicine; American Society of Parenteral and Enteral Nutrition. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Adult Critically Ill Patient: Society of Critical Care Medicine (SCCM) and American Society for Parenteral and Enteral Nutrition (A.S.P.E.N.). Crit Care Med. 2016 Feb;44(2):390-438. doi: 10.1097/CCM.0000000000001525. No abstract available.
- Results publication: PubMed 18230864Logemann JA, Gensler G, Robbins J, Lindblad AS, Brandt D, Hind JA, Kosek S, Dikeman K, Kazandjian M, Gramigna GD, Lundy D, McGarvey-Toler S, Miller Gardner PJ. A randomized study of three interventions for aspiration of thin liquids in patients with dementia or Parkinson's disease. J Speech Lang Hear Res. 2008 Feb;51(1):173-83. doi: 10.1044/1092-4388(2008/013).
- Results publication: PubMed 22242022Bardhan KD, Strugala V, Dettmar PW. Reflux revisited: advancing the role of pepsin. Int J Otolaryngol. 2012;2012:646901. doi: 10.1155/2012/646901. Epub 2011 Nov 10.
- Results publication: PubMed 24812000Hayat JO, Gabieta-Somnez S, Yazaki E, Kang JY, Woodcock A, Dettmar P, Mabary J, Knowles CH, Sifrim D. Pepsin in saliva for the diagnosis of gastro-oesophageal reflux disease. Gut. 2015 Mar;64(3):373-80. doi: 10.1136/gutjnl-2014-307049. Epub 2014 May 7.
- Derived from this study: PubMed 30200118Lu K, Zeng F, Li Y, Chen C, Huang M. A more physiological feeding process in ICU: Intermittent infusion with semi-solid nutrients (CONSORT-compliant). Medicine (Baltimore). 2018 Sep;97(36):e12173. doi: 10.1097/MD.0000000000012173.
- 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.
man huang, phD principal investigator
Second Affiliated Hospital, Zhejiang University, School of 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 semi-solid agent with standard enteral feeding and standard enteral feeding in people with Nutrition, Enteral, run by Second Affiliated Hospital, Zhejiang University, School of 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 2 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Ratio of the Enteral Nutrition (time frame: 3 days after receiving enteral nutrition). 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 NCT03017079, which also lists 8 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 2 Nov 2021.