Feeding Tube ComplicationPhase 4NCT04627844
Time to Feeding After PEG Tube Placement.
A Phase 4 study testing Immediate Feeding and Delayed Feeding in people with Feeding Tube Complication, run by Augusta University.
Trial summary
Trauma patients who require Percutaneous Endoscopic Gastrostomy (PEG) tube placement for feeding and who consent to be in the study will be randomized to receive feeding at either 6 hours after PEG placement as is routinely done or at 0 hours after PEG placement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feeding Tube Complication
- What is being tested?
- Immediate Feeding and Delayed Feeding
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to May 2023
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients who require PEG tube placement for feeding by the Trauma/Acute Care Surgery at our institution who are able to provide consent or whose legally authorized representative is able to provide consent for the patient.
Who cannot join
- Patients not receiving PEG placement
- Patients receiving PEG tube placement by a member of a different hospital service
- Patients under the age of 18 years old
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ideal Time to Enteral Feeding Following Percutaneous Endoscopic Gastrostomy Tube Placement
Trauma patients who require Percutaneous Endoscopic Gastrostomy (PEG) tube placement for feeding and who consent to be in the study will be randomized to receive feeding at either 6 hours after PEG placement as is routinely done or at 0 hours after PEG placement.
Read the detailed description
Critically ill patients share a common hypermetabolic response to injury, deterioration in lean body mass, and a high rate of septic complications. Route of nutrition administration influences the response to injury. A well-fed intestine absorbs nutrients while maintaining an effective barrier against pathogens, added by adequate peristalsis, mucin production, and immunoglobulin A secretion. In critical care patients, enteral nutritional therapy (EN) feeding has been shown to restores normal gut architecture and microflora, improve the immune system response, and aid the mucosa in withstanding insult to the system. Studies have shown that those on EN feeding have reduced morbidity and mortality rates as well as fewer infections and have less line-associated sepsis when compared to parenteral nutritional therapy (PN) feeding.
There are multiple EN feeding methods. Percutaneous endoscopic gastrostomy (PEG) was first introduced in 1980, and due to PEG being low cost, minimally invasive, and having no need for Bernal anesthetic in most cases, it is considered a better choice for the introduction of feeding than other methods. PEG tubes are usually entered for periods of tube feeding lasting more than 30 days, as well as when a nasogastric tube cannot but used for nutritional support. However, compared to naso-enteric tubes, PEG tubes are associated with fewer complications, greater patient comfort, better aesthetic appearance, and improved patient quality of life. For this reason, PEG is currently the method of choice for medium- and long- term enteral feeding. Previous studies have found complication rates within 30 days of PEG tube placement to be 10-15%.
Traditionally, post-PEG insertion, feeding was delayed until the next day for fear of peritoneal leakage risk after feeding. However, multiple studies have shown that feeding after PEG can be started early, within hours without a significant increase in the procedure-related morbidity or mortality and thereby reducing the healthier costs. There is currently no standard of practice for the timing of enteral feeding following PEG placement. Each group has different practice guidelines, and no national consensus has been established.
Studies have indicated that the initiation of tube feeding three to four hours after an uncomplicated PEG was safe, well-tolerated, and helped to reduce the hospital stay. A systematic analysis of five studies found that there were no significant differences between enteral feeds beginning at 3 hours versus feeds beginning at later times.
The investigator's current institution does not have a standard of practice for time to begin feeding after PEG tube placement; that decision is currently provider dependent. A survey of providers at the investigator's institutions indicated that the most common time to begin feeds is 6 hours, however, providers at the institution use varied times to beginning feeds between 0 and 24 hours after placement. The current literature supports a reduction in complications at feeds beginning under four hours. In fact, all studies investigating shorter time to feeds have found no associated increase in complications. No study to date has investigated immediately beginning tube feeds. There is no national consensus regarding feeding time after placement. Given the shown benefits of early enteral nutrition on reducing mortality and complications across a variety of conditions, the investigators believe early feeding has the strong potential to improve patient morbidity and mortality following PEG tube placement. This study aims to investigate whether beginning feeds immediately is a safe and effective management option for patients.
- Conditions
- Feeding Tube Complication
- Being tested
- Immediate Feeding, Delayed Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate FeedingDietary supplement
Standard tube feeds begun at an earlier time point
Delayed FeedingDietary supplement
Standard tube feeds begun at delayed time point
| Study group | Role | What they receive |
|---|---|---|
| Delayed Feeds | Placebo comparator | Patients will receive tube feeds beginning at 6 hours after PEG tube placement. This is our institutions current practice
Intervention Type: Dietary Receives: Dietary Supplement: Delayed Feeding |
| Immediate Feeds | Experimental | Patients will receive tube feeds beginning immediately after PEG tube placement.
Intervention Type: Dietary Receives: Dietary Supplement: Immediate Feeding |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe complication
Number of patients with a complication requiring return to operating room
Measured: Typically up to 4 weeks
Secondary outcomes (1)
Minor complication
Number of patients with a complication requiring cessation of feeds
Measured: Through study completion, an expected average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Feeding Tube ComplicationStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to receive feeding beginning at two time points.
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Lawson, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627844
- Sponsor's protocol ID
- 1656460-1
- Status last verified
- Nov 2020
- First submitted
- 25 Sep 2020
- Last updated
- 25 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bechtold ML, Matteson ML, Choudhary A, Puli SR, Jiang PP, Roy PK. Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis. Am J Gastroenterol. 2008 Nov;103(11):2919-24. doi: 10.1111/j.1572-0241.2008.02108.x. Epub 2008 Aug 21.
PubMed 18721239Choudhry U, Barde CJ, Markert R, Gopalswamy N. Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding. Gastrointest Endosc. 1996 Aug;44(2):164-7. doi: 10.1016/s0016-5107(96)70134-7.
PubMed 8858322Cristian D, Poalelungi A, Anghel A, Burcos T, Grigore R, Bertesteanu S, Richiteanu G, Grama F; -. Prophylactic Percutaneous Endoscopic Gastrostomy (PEG) - The Importance of Nutritonal Support in Patients with Head and Neck Cancers (HNCs) or Neurogenic Dysphagia (ND). Chirurgia (Bucur). 2015 Mar-Apr;110(2):129-36.
PubMed 26011834Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3. doi: 10.1097/00000658-199205000-00013.
PubMed 1616387McCarter TL, Condon SC, Aguilar RC, Gibson DJ, Chen YK. Randomized prospective trial of early versus delayed feeding after percutaneous endoscopic gastrostomy placement. Am J Gastroenterol. 1998 Mar;93(3):419-21. doi: 10.1111/j.1572-0241.1998.00419.x.
PubMed 9517650Rahnemai-Azar AA, Rahnemaiazar AA, Naghshizadian R, Kurtz A, Farkas DT. Percutaneous endoscopic gastrostomy: indications, technique, complications and management. World J Gastroenterol. 2014 Jun 28;20(24):7739-51. doi: 10.3748/wjg.v20.i24.7739.
PubMed 24976711Szary NM, Arif M, Matteson ML, Choudhary A, Puli SR, Bechtold ML. Enteral feeding within three hours after percutaneous endoscopic gastrostomy placement: a meta-analysis. J Clin Gastroenterol. 2011 Apr;45(4):e34-8. doi: 10.1097/MCG.0b013e3181eeb732.
PubMed 20733512
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ideal Time to Enteral Feeding Following Percutaneous Endoscopic Gastrostomy Tube Placement
- ClinicalTrials.gov ID
- NCT04627844
- Acronym / sponsor ID
- 1656460-1
- Conditions
- Feeding Tube Complication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 13 Nov 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.
Trauma patients who require Percutaneous Endoscopic Gastrostomy (PEG) tube placement for feeding and who consent to be in the study will be randomized to receive feeding at either 6 hours after PEG placement as is routinely done or at 0 hours after PEG placement.
Detailed description
Critically ill patients share a common hypermetabolic response to injury, deterioration in lean body mass, and a high rate of septic complications. Route of nutrition administration influences the response to injury. A well-fed intestine absorbs nutrients while maintaining an effective barrier against pathogens, added by adequate peristalsis, mucin production, and immunoglobulin A secretion. In critical care patients, enteral nutritional therapy (EN) feeding has been shown to restores normal gut architecture and microflora, improve the immune system response, and aid the mucosa in withstanding insult to the system. Studies have shown that those on EN feeding have reduced morbidity and mortality rates as well as fewer infections and have less line-associated sepsis when compared to parenteral nutritional therapy (PN) feeding.
There are multiple EN feeding methods. Percutaneous endoscopic gastrostomy (PEG) was first introduced in 1980, and due to PEG being low cost, minimally invasive, and having no need for Bernal anesthetic in most cases, it is considered a better choice for the introduction of feeding than other methods. PEG tubes are usually entered for periods of tube feeding lasting more than 30 days, as well as when a nasogastric tube cannot but used for nutritional support. However, compared to naso-enteric tubes, PEG tubes are associated with fewer complications, greater patient comfort, better aesthetic appearance, and improved patient quality of life. For this reason, PEG is currently the method of choice for medium- and long- term enteral feeding. Previous studies have found complication rates within 30 days of PEG tube placement to be 10-15%.
Traditionally, post-PEG insertion, feeding was delayed until the next day for fear of peritoneal leakage risk after feeding. However, multiple studies have shown that feeding after PEG can be started early, within hours without a significant increase in the procedure-related morbidity or mortality and thereby reducing the healthier costs. There is currently no standard of practice for the timing of enteral feeding following PEG placement. Each group has different practice guidelines, and no national consensus has been established.
Studies have indicated that the initiation of tube feeding three to four hours after an uncomplicated PEG was safe, well-tolerated, and helped to reduce the hospital stay. A systematic analysis of five studies found that there were no significant differences between enteral feeds beginning at 3 hours versus feeds beginning at later times.
The investigator's current institution does not have a standard of practice for time to begin feeding after PEG tube placement; that decision is currently provider dependent. A survey of providers at the investigator's institutions indicated that the most common time to begin feeds is 6 hours, however, providers at the institution use varied times to beginning feeds between 0 and 24 hours after placement. The current literature supports a reduction in complications at feeds beginning under four hours. In fact, all studies investigating shorter time to feeds have found no associated increase in complications. No study to date has investigated immediately beginning tube feeds. There is no national consensus regarding feeding time after placement. Given the shown benefits of early enteral nutrition on reducing mortality and complications across a variety of conditions, the investigators believe early feeding has the strong potential to improve patient morbidity and mortality following PEG tube placement. This study aims to investigate whether beginning feeds immediately is a safe and effective management option for patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized to receive feeding beginning at two time points.
| Arm | Type | Receives |
|---|---|---|
| Delayed Feeds | Placebo comparator | Dietary Supplement: Delayed FeedingPatients will receive tube feeds beginning at 6 hours after PEG tube placement. This is our institutions current practice Intervention Type: Dietary |
| Immediate Feeds | Experimental | Dietary Supplement: Immediate FeedingPatients will receive tube feeds beginning immediately after PEG tube placement. Intervention Type: Dietary |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients who require PEG tube placement for feeding by the Trauma/Acute Care Surgery at our institution who are able to provide consent or whose legally authorized representative is able to provide consent for the patient.
Key exclusion criteria (3 listed)
- Patients not receiving PEG placement
- Patients receiving PEG tube placement by a member of a different hospital service
- Patients under the age of 18 years old
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 |
|---|---|---|
| Immediate FeedingStandard tube feeds begun at an earlier time point | Dietary supplement | Immediate Feeds |
| Delayed FeedingStandard tube feeds begun at delayed time point | Dietary supplement | Delayed Feeds |
Primary outcome
Severe complication
Time frame: Typically up to 4 weeks
Number of patients with a complication requiring return to operating room
1 secondary outcome
Minor complication
Time frame: Through study completion, an expected average of one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2020.
- Background: PubMed 18721239Bechtold ML, Matteson ML, Choudhary A, Puli SR, Jiang PP, Roy PK. Early versus delayed feeding after placement of a percutaneous endoscopic gastrostomy: a meta-analysis. Am J Gastroenterol. 2008 Nov;103(11):2919-24. doi: 10.1111/j.1572-0241.2008.02108.x. Epub 2008 Aug 21.
- Background: PubMed 8858322Choudhry U, Barde CJ, Markert R, Gopalswamy N. Percutaneous endoscopic gastrostomy: a randomized prospective comparison of early and delayed feeding. Gastrointest Endosc. 1996 Aug;44(2):164-7. doi: 10.1016/s0016-5107(96)70134-7.
- Background: PubMed 26011834Cristian D, Poalelungi A, Anghel A, Burcos T, Grigore R, Bertesteanu S, Richiteanu G, Grama F; -. Prophylactic Percutaneous Endoscopic Gastrostomy (PEG) - The Importance of Nutritonal Support in Patients with Head and Neck Cancers (HNCs) or Neurogenic Dysphagia (ND). Chirurgia (Bucur). 2015 Mar-Apr;110(2):129-36.
- Background: PubMed 1616387Kudsk KA, Croce MA, Fabian TC, Minard G, Tolley EA, Poret HA, Kuhl MR, Brown RO. Enteral versus parenteral feeding. Effects on septic morbidity after blunt and penetrating abdominal trauma. Ann Surg. 1992 May;215(5):503-11; discussion 511-3. doi: 10.1097/00000658-199205000-00013.
- Background: PubMed 9517650McCarter TL, Condon SC, Aguilar RC, Gibson DJ, Chen YK. Randomized prospective trial of early versus delayed feeding after percutaneous endoscopic gastrostomy placement. Am J Gastroenterol. 1998 Mar;93(3):419-21. doi: 10.1111/j.1572-0241.1998.00419.x.
- Background: PubMed 24976711Rahnemai-Azar AA, Rahnemaiazar AA, Naghshizadian R, Kurtz A, Farkas DT. Percutaneous endoscopic gastrostomy: indications, technique, complications and management. World J Gastroenterol. 2014 Jun 28;20(24):7739-51. doi: 10.3748/wjg.v20.i24.7739.
- Background: PubMed 20733512Szary NM, Arif M, Matteson ML, Choudhary A, Puli SR, Bechtold ML. Enteral feeding within three hours after percutaneous endoscopic gastrostomy placement: a meta-analysis. J Clin Gastroenterol. 2011 Apr;45(4):e34-8. doi: 10.1097/MCG.0b013e3181eeb732.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate Feeding and Delayed Feeding in people with Feeding Tube Complication, run by Augusta University.
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 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 25 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Andrew Lawson, DO (540-998-2212, andlawson@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severe complication (time frame: Typically up to 4 weeks). 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 NCT04627844, which also lists 7 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 25 Nov 2020.