Critical IllnessNCT01934595
Optimal Protein Supplementation for Critically Ill Patients
A study testing Beneprotein in people with Critical Illness, run by University of Oklahoma at 1 site in United States.
Trial summary
It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Beneprotein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Sep 2017
- 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
- • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.
Who cannot join
- • Patients who cannot tolerate enteral nutrition
- Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract
- Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury.
- Patients with refractory hypotension unresponsive to vasoactive medications
- Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician)
- Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf.
Show all 10Show fewer
- Patients with end stage liver disease or undergoing liver transplant or liver resection surgery
- Patients whose physician thinks he/she should not participate
- Prisoners
- Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)
Trial locations and contacts
1 site in 1 country.
About this study
It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.
- Conditions
- Critical Illness
- Being tested
- Beneprotein
- Keywords
- Critically ill, Protein, Supplement, ICU, Protein synthesis
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeneproteinDietary supplement
The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.
| Study group | Role | What they receive |
|---|---|---|
| Varying amounts of Beneprotein | Experimental | 1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day Receives: Dietary Supplement: Beneprotein |
| 1 Gram - Standard Therapy given in ICU | Active comparator | 1 gram/kg/day of protein Receives: Dietary Supplement: Beneprotein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Organ failure free days
The primary outcome will be cumulative organ failure free days (defined as no aggressive medical support for the patient's vital organ systems; including cardiovascular, respiratory, renal, bone marrow, and liver.
Measured: 28 days
Secondary outcomes (1)
Mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2017 (estimated)
- Study completionSep 2017 (estimated)
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 OklahomaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen S Allen, MD, Principal investigator, OUHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934595
- Sponsor's protocol ID
- 3440
- Other IDs
- SCCM Vision
- Status last verified
- Jun 2017
- First submitted
- 29 Aug 2013
- Last updated
- 7 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Protein Supplementation for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT01934595
- Acronym / sponsor ID
- 3440
- Conditions
- Critical Illness
- Keywords
- Critically ill, Protein, Supplement, ICU, Protein synthesis
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 Sep 2013 (estimated)
- 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.
It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Varying amounts of Beneprotein | Experimental | Dietary Supplement: Beneprotein1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day |
| 1 Gram - Standard Therapy given in ICU | Active comparator | Dietary Supplement: Beneprotein1 gram/kg/day of protein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.
Key exclusion criteria (10 listed)
- • Patients who cannot tolerate enteral nutrition
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 |
|---|---|---|
| BeneproteinThe study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes. | Dietary supplement | 1 Gram - Standard Therapy given in ICU, Varying amounts of Beneprotein |
Primary outcome
Cumulative Organ failure free days
Time frame: 28 days
The primary outcome will be cumulative organ failure free days (defined as no aggressive medical support for the patient's vital organ systems; including cardiovascular, respiratory, renal, bone marrow, and liver.
1 secondary outcome
Mortality
Time frame: 28 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.
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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.
Karen S Allen, MD principal investigator
OUHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beneprotein in people with Critical Illness, run by University of Oklahoma 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 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: withdrawn, as of the sponsor's last update on 7 Jun 2017. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cumulative Organ failure free days (time frame: 28 days). 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 Jun 2017.