Nutrition DisorderPhase 3NCT03170401
Supplemental Enteral Protein in Critical Illness
A Phase 3 study testing Protein supplementation and Standard enteral nutrition in people with Nutrition Disorder and Trauma, run by University of Washington at 1 site in United States.
Trial summary
The aim of this study is too determine the effect of enteral protein supplementation on biochemical measures of inflammation and protein metabolism in critically ill surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nutrition Disorder, Trauma, Critical Illness
- What is being tested?
- Protein supplementation and Standard enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to Dec 2022
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Critically ill adult trauma (blunt and penetrating) victims
- Other critically ill surgical patients
- enteral nutrition required during the first 96 hours after injury
- expected to require nutritional support for at least 1 week
Who cannot join
- Significant chronic organ failure,
- severe malnutrition pre-existing prior to ICU admission
- not expected to survive from their traumatic injuries.
- intestinal discontinuity
- short bowel syndrome
- bowel obstruction
Show all 10Show fewer
- enterocutaneous fistula
- intestinal ischemia
- massive gastrointestinal hemorrhage
- inability to obtain enteral access.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harborview Medical Center
Seattle, Washington, 98104
About this study
Official title: Protein-enhanced Enteral Nutrition and Metabolomics in Critically Ill Trauma and Surgical Patients
The aim of this study is too determine the effect of enteral protein supplementation on biochemical measures of inflammation and protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness.
Hypothesis: That early supplemental protein will increase serum concentrations of transthyretin at three weeks after the onset of illness or injury. Secondarily, the investigators will test whether supplementation, reduces infectious complications and increases ventilator-free days.
Read the detailed description
Critically ill patients are frequently undernourished. The investigator's observations indicate that surgical and trauma patients who require artificial nutrition are likely to be markedly undernourished during the first week of critical illness, will often require intensive and costly support for organ failure, have prolonged stays in the intensive care unit and extended hospitalizations. Nitrogen deficits are typically greater and receive less attention than caloric deficits. In some respects, the focus on avoiding caloric deficits may have missed the mark. A broader consideration of nutrient needs, such as protein, is required. For instance, there are observational data supporting the notion that protein intake is at least as important as caloric intake in promoting recovery in critical illness. Only recently have national guidelines (ASPEN 2016) begun to specifically address protein requirements (1.5 - 2.0 g/kg/day). For a number of years, the approach to these critically ill patients has included weekly measurements of 24 hour urine nitrogen excretion in order to better understand the protein deficits that develop. Based upon physician preference, the investigators can then use enteral protein supplementation to match the urinary nitrogen excretion in order to achieve net "zero" nitrogen balance. With supplemental protein administration, physicians are able to reduce this deficit and in some cases, generate a positive nitrogen balance. However, there are no data to indicate that this approach (which is included as part of the 2016 ASPEN guidelines) improves clinical outcomes. The most obvious mechanism whereby supplemental protein may influence outcomes by providing more metabolic substrate for protein building. Feeding the gut likely creates a more anabolic environment and additional protein may facilitate anabolism. However, it is not known whether protein supplementation improves markers of anabolism and protein synthesis. In this study, the investigators will measure the anabolic effect of supplemental protein by following serum transthyretin concentrations as part of the standard clinical care.The investigators postulate that supplemental protein will attenuate the drop in comparison to no supplemental protein and will hasten the return to normal concentrations.
The proposed study will test whether early, and standardized protein supplementation: (1) Increases protein delivery during the first 2 weeks after injury, (2) increases serum transthyretin concentrations at 3 weeks after injury (3) increases ventilator-free days.
Study aims:
The aim of this study is to determine the effect of enteral protein supplementation on biochemical measures of protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness. However, this study will not enroll a sufficient number of subjects to adequately test for differences in these clinical end-points.
Hypothesis: That early supplemental protein will, increase serum concentrations of transthyretin at three weeks after injury. Secondarily, the investigators will test whether supplementation reduces infectious complications and increases ventilator-free days.
- Conditions
- Nutrition Disorder, Trauma, Critical Illness
- Being tested
- Protein supplementation, Standard enteral nutrition
- Medical subject headings
- Nutrition Disorders, Wounds and Injuries, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein supplementationDietary supplement
enteral protein supplementation
Standard enteral nutritionOther
Standard enteral nutrition.
| Study group | Role | What they receive |
|---|---|---|
| no protein supplementation | Active comparator | subjects receiving enteral nutrition without any protein supplementation Receives: Other: Standard enteral nutrition |
| protein supplementation | Experimental | subjects receiving enteral nutrition with additional protein supplementation Receives: Dietary Supplement: Protein supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Concentrations of Transthyretin at 3 Weeks After Injury.
Transthyretin is a circulating biomarker of nutritional status and protein synthesis.
Measured: 3 weeks after admission for injury
Secondary outcomes (2)
Ventilator-free Days.
Ventilator-free days will measured in the standard way and indicate the number of days a subject was alive and not receiving mechanical ventilation during the first 28 days.
Measured: Within 28 days following admission to hospital following injury.
Ventilator Associated Pneumonia.
Pneumonia diagnosed while the patient is receiving mechanical ventilation as recorded in the institutional administrative trauma registry and ICU quality assurance database.
Measured: At any point during the hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study startNov 2016
- Primary completionDec 2022
- Study completionDec 2022
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.
- Other trials for Nutrition DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Grant E. O'Keefe, University of Washington
- Investigators
- Grant O'Keefe, MD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170401
- Sponsor's protocol ID
- STUDY00007918
- Other IDs
- 1R01GM127790-01A1
- Status last verified
- May 2024
- First submitted
- 18 Apr 2017
- Last updated
- 5 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein-enhanced Enteral Nutrition and Metabolomics in Critically Ill Trauma and Surgical Patients
- ClinicalTrials.gov ID
- NCT03170401
- Acronym / sponsor ID
- STUDY00007918
- Conditions
- Nutrition Disorder, Trauma, Critical Illness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 31 May 2017 (actual)
- Results
- Posted 5 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is too determine the effect of enteral protein supplementation on biochemical measures of inflammation and protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness.
Hypothesis: That early supplemental protein will increase serum concentrations of transthyretin at three weeks after the onset of illness or injury. Secondarily, the investigators will test whether supplementation, reduces infectious complications and increases ventilator-free days.
Detailed description
Critically ill patients are frequently undernourished. The investigator's observations indicate that surgical and trauma patients who require artificial nutrition are likely to be markedly undernourished during the first week of critical illness, will often require intensive and costly support for organ failure, have prolonged stays in the intensive care unit and extended hospitalizations. Nitrogen deficits are typically greater and receive less attention than caloric deficits. In some respects, the focus on avoiding caloric deficits may have missed the mark. A broader consideration of nutrient needs, such as protein, is required. For instance, there are observational data supporting the notion that protein intake is at least as important as caloric intake in promoting recovery in critical illness. Only recently have national guidelines (ASPEN 2016) begun to specifically address protein requirements (1.5 - 2.0 g/kg/day). For a number of years, the approach to these critically ill patients has included weekly measurements of 24 hour urine nitrogen excretion in order to better understand the protein deficits that develop. Based upon physician preference, the investigators can then use enteral protein supplementation to match the urinary nitrogen excretion in order to achieve net "zero" nitrogen balance. With supplemental protein administration, physicians are able to reduce this deficit and in some cases, generate a positive nitrogen balance. However, there are no data to indicate that this approach (which is included as part of the 2016 ASPEN guidelines) improves clinical outcomes. The most obvious mechanism whereby supplemental protein may influence outcomes by providing more metabolic substrate for protein building. Feeding the gut likely creates a more anabolic environment and additional protein may facilitate anabolism. However, it is not known whether protein supplementation improves markers of anabolism and protein synthesis. In this study, the investigators will measure the anabolic effect of supplemental protein by following serum transthyretin concentrations as part of the standard clinical care.The investigators postulate that supplemental protein will attenuate the drop in comparison to no supplemental protein and will hasten the return to normal concentrations.
The proposed study will test whether early, and standardized protein supplementation: (1) Increases protein delivery during the first 2 weeks after injury, (2) increases serum transthyretin concentrations at 3 weeks after injury (3) increases ventilator-free days.
Study aims:
The aim of this study is to determine the effect of enteral protein supplementation on biochemical measures of protein metabolism in critically ill surgical patients. The investigators will also collect data on important clinical outcomes, including infectious complications, duration of mechanical ventilation and other measures of recovery from critical illness. However, this study will not enroll a sufficient number of subjects to adequately test for differences in these clinical end-points.
Hypothesis: That early supplemental protein will, increase serum concentrations of transthyretin at three weeks after injury. Secondarily, the investigators will test whether supplementation reduces infectious complications and increases ventilator-free days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no protein supplementation | Active comparator | Other: Standard enteral nutritionsubjects receiving enteral nutrition without any protein supplementation |
| protein supplementation | Experimental | Dietary Supplement: Protein supplementationsubjects receiving enteral nutrition with additional protein supplementation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Critically ill adult trauma (blunt and penetrating) victims
- Other critically ill surgical patients
- enteral nutrition required during the first 96 hours after injury
- expected to require nutritional support for at least 1 week
Key exclusion criteria (10 listed)
- Significant chronic organ failure,
- severe malnutrition pre-existing prior to ICU admission
- not expected to survive from their traumatic injuries.
- intestinal discontinuity
- short bowel syndrome
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 |
|---|---|---|
| Protein supplementationenteral protein supplementation | Dietary supplement | protein supplementation |
| Standard enteral nutritionStandard enteral nutrition. | Other | no protein supplementation |
Primary outcome
Serum Concentrations of Transthyretin at 3 Weeks After Injury.
Time frame: 3 weeks after admission for injury
Transthyretin is a circulating biomarker of nutritional status and protein synthesis.
2 secondary outcomes
Ventilator-free Days.
Time frame: Within 28 days following admission to hospital following injury.
Ventilator Associated Pneumonia.
Time frame: At any point during the hospitalization.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Grant O'Keefe, MD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Protein supplementation and Standard enteral nutrition in people with Nutrition Disorder and Trauma, run by University of Washington 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 4 inclusion and 10 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 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2024). 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?
Serum Concentrations of Transthyretin at 3 Weeks After Injury. (time frame: 3 weeks after admission for injury). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.