Glucose Metabolism DisordersELFNCT03566992
Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF)
A study testing Gastric in people with Glucose Metabolism Disorders and Critical Illness, run by Winchester Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effect of location of feeding on glycemic control in critically ill patients. The investigators hypothesize that glycemic control in critically ill patients who receive enteral nutrition through postpyloric location (beyond stomach) will have better glycemic control… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glucose Metabolism Disorders, Critical Illness
- What is being tested?
- Gastric
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 Sep 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years or above) patients admitted in the critical care unit on mechanical ventilation for at least 48 hours
- Orders for tube feeding
Who cannot join
- Intubated for less than 48 hours (suspected insufficient time for the role of feeding mode to affect glycemic control)
- Patients not being fed (such as DKA, GI bleed, obstruction, ileus, etc)
- Pre-existing PEG/PEJ tubes
- Surgically altered upper and middle GI tract such as partial gastrectomy, gastric bypass surgeries etc. (patients with ileostomy and colostomy may still be included if the enteral route is used for nutrition)
- No informed consent
- Primary attending finds medical necessity to have a specific type of tube preventing randomization
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Winchester Medical Center
Winchester, Virginia, 22602
Brett Baney, MS, RD
About this study
The purpose of this study is to investigate the effect of location of feeding on glycemic control in critically ill patients.
The investigators hypothesize that glycemic control in critically ill patients who receive enteral nutrition through postpyloric location (beyond stomach) will have better glycemic control compared to critically ill patients fed gastrically.
Read the detailed description
Randomization will happen after initial stabilization phase which may last up to 24 hours till when patient may or may not have an enteric access. If enteral access is gained and patient is screened in for the study using inclusion and exclusion criteria, a consent shall be obtained for enrollment. The tube may be continued to be used if randomized in group A. If patient is randomized to group B, a postpyloric placement will be achieved.
Randomization using computer software and a unique identification number will be assigned to every intubated patients who may need mechanical ventilation or tube feed for more than 48 hours.
Randomization will be considered incomplete and the case will be excluded if the process of assigning group, confirmation of placement of appropriate group specific tube and nutrition is not initiated within 24 hours.
If patient is randomized into group A, a bedside RN or the intensivist will place a Salem Sump gastric tube. A nutrition consult for tube feed will be obtained. Confirmation of gastric placement and not a postpyloric placement will be based on the length of the orogastric/nasogastric tube and a standard chest radiograph obtained routinely after intubation. The NG or OG tube should not be more than 65 cm in most cases to prevent it from migrating into the postpyloric location. A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained. Data collection and Salem Sump placement will be confirmed by the studying team and will not be known to the RD prescribing the nutrition.
If a patient is randomized into group B, a trained RN or RD will place the small-bore feeding feeding tube in the postpyloric position. The effort will be to assure jejunal placement, but postpyloric placement should be sufficient. If for some reason, the small-bore tube cannot be passed beyond pylorus, then sufficient length will be left in IRB the stomach and the case will be noted to have not had the postpyloric placement.
A per protocol analysis and an intention to treat analysis will be carried in the end to take into consideration cases when placement of tube in certain location could not be achieved.
If a feeding tube becomes occluded, it will be replaced with a new tube within 12 hours. If the patient had a postpyloric tube and the new tube cannot be positioned in the postpyloric location, the patient's involvement in the study will be halted (no further data collection).
A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained.
- Conditions
- Glucose Metabolism Disorders, Critical Illness
- Being tested
- Gastric
- Medical subject headings
- Glucose Metabolism Disorders, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastricProcedure or surgery
Placement of a nasoenteric tube
| Study group | Role | What they receive |
|---|---|---|
| Gastric Tube Placement | Active comparator | Nasoenteric tube placed in the stomach. Receives: Procedure: Gastric |
| Small bowel | Experimental | Nasoenteric tube placed in the small bowel. Receives: Procedure: Gastric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasoenteric tube placement
Investigate the effect of location of feeding on glycemic control
Measured: Intubated patients >48 hours and up to 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start1 May 2017
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Sep 2018 (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 Glucose Metabolism DisordersStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winchester Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Halyard Health
- Responsible party
- Principal investigator, Padmaraj Duvvuri, Winchester Medical Center
- Investigators
- Padmaraj Duvvuri, MD, Study director, Winchester Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566992
- Sponsor's protocol ID
- WinchesterMC
- Acronym
- ELF
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Metheny NA, Clouse RE, Chang YH, Stewart BJ, Oliver DA, Kollef MH. Tracheobronchial aspiration of gastric contents in critically ill tube-fed patients: frequency, outcomes, and risk factors. Crit Care Med. 2006 Apr;34(4):1007-15. doi: 10.1097/01.CCM.0000206106.65220.59.
PubMed 16484901Di Bartolomeo AE, Chapman MJ, V Zaknic A, Summers MJ, Jones KL, Nguyen NQ, Rayner CK, Horowitz M, Deane AM. Comparative effects on glucose absorption of intragastric and post-pyloric nutrient delivery in the critically ill. Crit Care. 2012 Sep 17;16(5):R167. doi: 10.1186/cc11522.
PubMed 22985684Pournaras DJ, Aasheim ET, Bueter M, Ahmed AR, Welbourn R, Olbers T, le Roux CW. Effect of bypassing the proximal gut on gut hormones involved with glycemic control and weight loss. Surg Obes Relat Dis. 2012 Jul-Aug;8(4):371-4. doi: 10.1016/j.soard.2012.01.021. Epub 2012 Mar 3.
PubMed 22480751Luttikhold J, van Norren K, Rijna H, Buijs N, Ankersmit M, Heijboer AC, Gootjes J, Hartmann B, Holst JJ, van Loon LJ, van Leeuwen PA. Jejunal feeding is followed by a greater rise in plasma cholecystokinin, peptide YY, glucagon-like peptide 1, and glucagon-like peptide 2 concentrations compared with gastric feeding in vivo in humans: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):435-43. doi: 10.3945/ajcn.115.116251. Epub 2016 Jan 13.
PubMed 26762368
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Location of Feeding on Glycemic Control in Critically Ill Patients (ELF)
- ClinicalTrials.gov ID
- NCT03566992
- Acronym / sponsor ID
- ELF / WinchesterMC
- Conditions
- Glucose Metabolism Disorders, Critical Illness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Winchester Medical CenterUniversity, hospital or other
- Collaborators
- Halyard Health
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 25 Jun 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 purpose of this study is to investigate the effect of location of feeding on glycemic control in critically ill patients.
The investigators hypothesize that glycemic control in critically ill patients who receive enteral nutrition through postpyloric location (beyond stomach) will have better glycemic control compared to critically ill patients fed gastrically.
Detailed description
Randomization will happen after initial stabilization phase which may last up to 24 hours till when patient may or may not have an enteric access. If enteral access is gained and patient is screened in for the study using inclusion and exclusion criteria, a consent shall be obtained for enrollment. The tube may be continued to be used if randomized in group A. If patient is randomized to group B, a postpyloric placement will be achieved.
Randomization using computer software and a unique identification number will be assigned to every intubated patients who may need mechanical ventilation or tube feed for more than 48 hours.
Randomization will be considered incomplete and the case will be excluded if the process of assigning group, confirmation of placement of appropriate group specific tube and nutrition is not initiated within 24 hours.
If patient is randomized into group A, a bedside RN or the intensivist will place a Salem Sump gastric tube. A nutrition consult for tube feed will be obtained. Confirmation of gastric placement and not a postpyloric placement will be based on the length of the orogastric/nasogastric tube and a standard chest radiograph obtained routinely after intubation. The NG or OG tube should not be more than 65 cm in most cases to prevent it from migrating into the postpyloric location. A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained. Data collection and Salem Sump placement will be confirmed by the studying team and will not be known to the RD prescribing the nutrition.
If a patient is randomized into group B, a trained RN or RD will place the small-bore feeding feeding tube in the postpyloric position. The effort will be to assure jejunal placement, but postpyloric placement should be sufficient. If for some reason, the small-bore tube cannot be passed beyond pylorus, then sufficient length will be left in IRB the stomach and the case will be noted to have not had the postpyloric placement.
A per protocol analysis and an intention to treat analysis will be carried in the end to take into consideration cases when placement of tube in certain location could not be achieved.
If a feeding tube becomes occluded, it will be replaced with a new tube within 12 hours. If the patient had a postpyloric tube and the new tube cannot be positioned in the postpyloric location, the patient's involvement in the study will be halted (no further data collection).
A standard enteral tube feed formula will be initiated. Blood sugars checked via basic metabolic (at least daily) panel and point-of-care glucose tests (at least every 6 hours) will be obtained.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gastric Tube Placement | Active comparator | Procedure: GastricNasoenteric tube placed in the stomach. |
| Small bowel | Experimental | Procedure: GastricNasoenteric tube placed in the small bowel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (18 years or above) patients admitted in the critical care unit on mechanical ventilation for at least 48 hours
- Orders for tube feeding
Key exclusion criteria (6 listed)
- Intubated for less than 48 hours (suspected insufficient time for the role of feeding mode to affect glycemic control)
- Patients not being fed (such as DKA, GI bleed, obstruction, ileus, etc)
- Pre-existing PEG/PEJ tubes
- Surgically altered upper and middle GI tract such as partial gastrectomy, gastric bypass surgeries etc. (patients with ileostomy and colostomy may still be included if the enteral route is used for nutrition)
- No informed consent
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 |
|---|---|---|
| GastricPlacement of a nasoenteric tube | Procedure or surgery | Gastric Tube Placement, Small bowel |
Primary outcome
Nasoenteric tube placement
Time frame: Intubated patients >48 hours and up to 7 days.
Investigate the effect of location of feeding on glycemic control
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Background: PubMed 16484901Metheny NA, Clouse RE, Chang YH, Stewart BJ, Oliver DA, Kollef MH. Tracheobronchial aspiration of gastric contents in critically ill tube-fed patients: frequency, outcomes, and risk factors. Crit Care Med. 2006 Apr;34(4):1007-15. doi: 10.1097/01.CCM.0000206106.65220.59.
- Background: PubMed 22985684Di Bartolomeo AE, Chapman MJ, V Zaknic A, Summers MJ, Jones KL, Nguyen NQ, Rayner CK, Horowitz M, Deane AM. Comparative effects on glucose absorption of intragastric and post-pyloric nutrient delivery in the critically ill. Crit Care. 2012 Sep 17;16(5):R167. doi: 10.1186/cc11522.
- Background: PubMed 22480751Pournaras DJ, Aasheim ET, Bueter M, Ahmed AR, Welbourn R, Olbers T, le Roux CW. Effect of bypassing the proximal gut on gut hormones involved with glycemic control and weight loss. Surg Obes Relat Dis. 2012 Jul-Aug;8(4):371-4. doi: 10.1016/j.soard.2012.01.021. Epub 2012 Mar 3.
- Background: PubMed 26762368Luttikhold J, van Norren K, Rijna H, Buijs N, Ankersmit M, Heijboer AC, Gootjes J, Hartmann B, Holst JJ, van Loon LJ, van Leeuwen PA. Jejunal feeding is followed by a greater rise in plasma cholecystokinin, peptide YY, glucagon-like peptide 1, and glucagon-like peptide 2 concentrations compared with gastric feeding in vivo in humans: a randomized trial. Am J Clin Nutr. 2016 Feb;103(2):435-43. doi: 10.3945/ajcn.115.116251. Epub 2016 Jan 13.
- Individual participant dataSharing planned: Undecided
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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.
Padmaraj Duvvuri, MD study director
Winchester Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric in people with Glucose Metabolism Disorders and Critical Illness, run by Winchester Medical Center at 1 site in United States.
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 2 inclusion and 6 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 26 Jun 2018. 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 United States. 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 Brett Baney, MS, RD (540-536-1631, bbaney@valleyhealthlink.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasoenteric tube placement (time frame: Intubated patients >48 hours and up to 7 days.). 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 NCT03566992, 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 26 Jun 2018.