Critical IllnessNCT03733782
Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients
A study testing Modular enteral protein - Prosource in people with Critical Illness and Malnutrition, run by University of Washington.
Trial summary
Published guidelines recommend at least 2 gm/kg/day of protein for critically ill surgical patients. It may not be possible to achieve this level of intake using polymeric enteral nutritional formula and protein or amino acid supplementation will be necessary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Malnutrition, Enteral Nutrition
- What is being tested?
- Modular enteral protein - Prosource
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2016to 30 Sep 2016
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All critically ill adult trauma (blunt and penetrating) and all surgical critical care patients ≥ 18 years old patients where enteral nutrition is begun by the attending physician during the first 48 hours after injury, and are 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 due to the severity of their illness or 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
About this study
Published guidelines recommend at least 2 gm/kg/day of protein for critically ill surgical patients. It may not be possible to achieve this level of intake using polymeric enteral nutritional formula and protein or amino acid supplementation will be necessary. This was a retrospective cohort study in which the investigators reviewed critically ill trauma and surgical patients treated with supplemental enteral protein according to a protocol aimed to deliver a total of 2 gm/kg/day of protein. The investigators studied detailed nutritional data from a 2 week period after admission and obtained additional data through discharge to determine caloric intake, protein intake and complications. The investigators also compared urine nitrogen excretion and visceral protein (transthyretin) concentrations between those who received early supplementation with those who did not.
Read the detailed description
This is a retrospective analysis of a treatment approach designed to increase enteral protein intake in critically ill surgical patients. The study investigators recently developed guidelines aimed to improve early enteral protein delivery in critically ill patients. The guidelines were tested for 6 months; applying it to 53 patients (April to September, 2016) in order to determine its safety and effectiveness. All subjects were admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. The guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending intensivist within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine <2.0 mg/dl.
In order to compare biochemical markers of nutritional support, the investigators used the electronic medical record to identify all patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week. In addition to measuring TUN, the investigators also monitor the response to nutritional support and recovery from critical illness using serum transthyretin (also known as prealbumin).
This review resulted in a cohort of 118 patients who underwent at least one TUN measurement. Of these, 27 received early protein supplementation and 91 did not and these provide the basis for the comparisons described below. We wanted to measure the effect of early supplemental protein treatment on nitrogen excretion and on serum transthyretin concentrations as the patients recovered. We therefore, compared nitrogen excretion and serum transthyretin between those who received early supplementation and those who did not.
- Being tested
- Modular enteral protein - Prosource
- Medical subject headings
- Critical Illness, Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular enteral protein - ProsourceDietary supplement
Supplemental protein (2 gm/kg/day of Prosource; Medtrition, Lancaster, PA) was administered via the nasal/oral feeding tube in 60 - 180 ml bolus infusions 2 - 4 times per day, independently of the enteral formula received. That is, the daily target amount of protein was initially administered as the supplement boluses and only after the enteral formula infusion approached the target rate was the amount of supplement decreased. Supplemental protein was reduced by 50% once the patient received 75% of targeted caloric intake over the previous day (0700 - 0700). Once the patient reached the target caloric intake for 48 hours, the amount of supplemental protein was decreased in order that the total protein prescribed equaled 2 gm/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| Modular enteral protein - Prosource | Active comparator | Subjects are patients admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. Guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending physician within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine < 2.0 mg/dl. Receives: Dietary Supplement: Modular enteral protein - Prosource |
| Control group | No intervention | The investigators used the electronic medical record to identify control subjects. These were patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enteral protein intake
Amount of enteral protein intake during first 14 days
Measured: 14 days
Total urine nitrogen excretion
Nitrogen excreted in urine over 24 hour period
Measured: up to 2 weeks after admission
Secondary outcomes (1)
Ventilator-free days
Days alive and not receiving mechanical ventilation in initial 28 days
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start1 Apr 2016
- Primary completion30 Sep 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Grant E. O'Keefe, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03733782
- Sponsor's protocol ID
- STUDY00002185
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 7 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Enteral Protein Intake in Critically Ill Trauma and Surgical Patients
- ClinicalTrials.gov ID
- NCT03733782
- Acronym / sponsor ID
- STUDY00002185
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 30 Sep 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 7 Nov 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.
Published guidelines recommend at least 2 gm/kg/day of protein for critically ill surgical patients. It may not be possible to achieve this level of intake using polymeric enteral nutritional formula and protein or amino acid supplementation will be necessary. This was a retrospective cohort study in which the investigators reviewed critically ill trauma and surgical patients treated with supplemental enteral protein according to a protocol aimed to deliver a total of 2 gm/kg/day of protein. The investigators studied detailed nutritional data from a 2 week period after admission and obtained additional data through discharge to determine caloric intake, protein intake and complications. The investigators also compared urine nitrogen excretion and visceral protein (transthyretin) concentrations between those who received early supplementation with those who did not.
Detailed description
This is a retrospective analysis of a treatment approach designed to increase enteral protein intake in critically ill surgical patients. The study investigators recently developed guidelines aimed to improve early enteral protein delivery in critically ill patients. The guidelines were tested for 6 months; applying it to 53 patients (April to September, 2016) in order to determine its safety and effectiveness. All subjects were admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. The guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending intensivist within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine <2.0 mg/dl.
In order to compare biochemical markers of nutritional support, the investigators used the electronic medical record to identify all patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week. In addition to measuring TUN, the investigators also monitor the response to nutritional support and recovery from critical illness using serum transthyretin (also known as prealbumin).
This review resulted in a cohort of 118 patients who underwent at least one TUN measurement. Of these, 27 received early protein supplementation and 91 did not and these provide the basis for the comparisons described below. We wanted to measure the effect of early supplemental protein treatment on nitrogen excretion and on serum transthyretin concentrations as the patients recovered. We therefore, compared nitrogen excretion and serum transthyretin between those who received early supplementation and those who did not.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modular enteral protein - Prosource | Active comparator | Dietary Supplement: Modular enteral protein - ProsourceSubjects are patients admitted to the surgical intensive care unit and identified by one of the investigators as being appropriate for protein supplementation. Guidelines required that patients were: 1. Deemed ready to start enteral nutritional support by the attending physician within 72 hours of admission to the intensive care unit, 2. No contraindications to full enteral support, 3. No history of chronic liver disease, 4. Serum creatinine < 2.0 mg/dl. |
| Control group | No intervention | –The investigators used the electronic medical record to identify control subjects. These were patients admitted to the surgical intensive care unit who were in the ICU long enough to undergo testing of 24 hour urine nitrogen excretion from January to December 2016.8 As part of standard clinical practice, measurement of urine nitrogen excretion is performed in patients who are in the ICU and receiving nutritional support for more than one week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All critically ill adult trauma (blunt and penetrating) and all surgical critical care patients ≥ 18 years old patients where enteral nutrition is begun by the attending physician during the first 48 hours after injury, and are 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 due to the severity of their illness or 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 |
|---|---|---|
| Modular enteral protein - ProsourceSupplemental protein (2 gm/kg/day of Prosource; Medtrition, Lancaster, PA) was administered via the nasal/oral feeding tube in 60 - 180 ml bolus infusions 2 - 4 times per day, independently of the enteral formula received. That is, the daily target amount of protein was initially administered as the supplement boluses and only after the enteral formula infusion approached the target rate was the amount of supplement decreased. Supplemental protein was reduced by 50% once the patient received 75% of targeted caloric intake over the previous day (0700 - 0700). Once the patient reached the target caloric intake for 48 hours, the amount of supplemental protein was decreased in order that the total protein prescribed equaled 2 gm/kg/day. | Dietary supplement | Modular enteral protein - Prosource |
Primary outcome
Enteral protein intake
Time frame: 14 days
Amount of enteral protein intake during first 14 days
Total urine nitrogen excretion
Time frame: up to 2 weeks after admission
Nitrogen excreted in urine over 24 hour period
1 secondary outcome
Ventilator-free days
Time frame: Up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Modular enteral protein - Prosource in people with Critical Illness and Malnutrition, run by University of Washington.
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 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 7 Nov 2018. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Enteral protein intake (time frame: 14 days). The study lists 2 primary outcomes in all. 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 7 Nov 2018.