Protein DeficiencyOPINiBNCT02990065
Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients
A study testing PROTEIN SUPPLEMENTATION in people with Protein Deficiency, run by University of Padova.
Trial summary
The purposes of the study are: To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation; To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Protein Deficiency
- What is being tested?
- PROTEIN SUPPLEMENTATION
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 30 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Receiving PN and/or EN nutrition
- Indwelling urinary catheter
- Mechanically ventilated patients
Who cannot join
- Age < 18 years
- Chronic renal or hepatic failure
- Current or history (past 6 months) of GI bleeding
- BMI >30 kg/m2 o <18 kg/m2
- Terminally ill patients
- Pregnancy
About this study
Official title: Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)
The purposes of the study are:
- To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation;
- To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. Creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated BUN.
- To determine if there is a difference in ICU mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.
- Conditions
- Protein Deficiency
- Being tested
- PROTEIN SUPPLEMENTATION
- Keywords
- PROTEIN SUPPLEMENTATION, NUTRITIONAL STATUS
- Medical subject headings
- Protein Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PROTEIN SUPPLEMENTATIONDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| PROTEIN-FORTIFIED DIET | Experimental | The protein-fortified diet consists on an energy goal based on REE measurement and a protein target based on the most recent literature recommendations (1.2-2 g/kg/die) (2). Daily caloric requirement, and subsequent protein content, of patients enrolled in the intervention group will be calculated using formulas in Table 1 (10, 12, 13). For each patient will be calculated the Resting Energy Expenditure (REE) and daily protein requirement (1.2-2g/kg/die of body weight registered at the admission) and the corresponding caloric intake (1g = 4 kcal). Finally, total daily caloric intake will be calculated by adding kcal from protein (1g = 4kcal) on kcal from non-protein (50% of REE). Receives: Dietary Supplement: PROTEIN SUPPLEMENTATION |
| STANDARD DIET | No intervention | The standard diet consists on an energy goal based on weight formula (20-25 kcal/kg/die). According to the ICU nutritional protocol, EN is started at an initial rate of 10ml/h, and increased by 20ml/h every 12 hours in the absence of significant gastric residuals (<250ml), with the aim of reaching the energy goal within 72 hours from admission. The EN formulae used are standard (1-1,5 kcal/ml, 40g/l protein). If enteral nutrition is not tolerated or is not indicated, supplemental PN is used to make up the energy shortfall. The PN formula used is standard (1000 kcal/l, 37 g/l protein). |
What is being measured
The primary outcome is the main question the study is designed to answer.
nitrogen balance (gr)
(gr)
Measured: change from baseline through study completion, an average of 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start1 Jan 2017
- Primary completion31 May 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Protein DeficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Gregori, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02990065
- Sponsor's protocol ID
- OPINiB 2016
- Acronym
- OPINiB
- Status last verified
- Apr 2021
- First submitted
- 28 Nov 2016
- Last updated
- 28 Apr 2021
- Results posted
- No
Publications
Danielis M, Lorenzoni G, Cavaliere L, Ruffolo M, Peressoni L, De Monte A, Muzzi R, Beltrame F, Gregori D. Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 9;6(5):e78. doi: 10.2196/resprot.7100.
PubMed 28487264
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)
- ClinicalTrials.gov ID
- NCT02990065
- Acronym / sponsor ID
- OPINiB / OPINiB 2016
- Conditions
- Protein Deficiency
- Keywords
- PROTEIN SUPPLEMENTATION, NUTRITIONAL STATUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 12 Dec 2016 (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.
The purposes of the study are:
- To strictly ensure the appropriate level of protein and caloric provision in critical illness, according to the latest literature recommendation;
- To determine if an association exists between protein intake and nitrogen balance in the context of a nutrition with appropriate protein provision based on the latest literature recommendations, rather than in a standard diet with a caloric target weight-based. Creatinine clearance will also be evaluated to determine if there is any harmful effect to the kidney secondary to an elevated BUN.
- To determine if there is a difference in ICU mortality rate between the current nutrition standard and a hyperproteic nutrition protocol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROTEIN-FORTIFIED DIET | Experimental | Dietary Supplement: PROTEIN SUPPLEMENTATIONThe protein-fortified diet consists on an energy goal based on REE measurement and a protein target based on the most recent literature recommendations (1.2-2 g/kg/die) (2). Daily caloric requirement, and subsequent protein content, of patients enrolled in the intervention group will be calculated using formulas in Table 1 (10, 12, 13). For each patient will be calculated the Resting Energy Expenditure (REE) and daily protein requirement (1.2-2g/kg/die of body weight registered at the admission) and the corresponding caloric intake (1g = 4 kcal). Finally, total daily caloric intake will be calculated by adding kcal from protein (1g = 4kcal) on kcal from non-protein (50% of REE). |
| STANDARD DIET | No intervention | –The standard diet consists on an energy goal based on weight formula (20-25 kcal/kg/die). According to the ICU nutritional protocol, EN is started at an initial rate of 10ml/h, and increased by 20ml/h every 12 hours in the absence of significant gastric residuals (<250ml), with the aim of reaching the energy goal within 72 hours from admission. The EN formulae used are standard (1-1,5 kcal/ml, 40g/l protein). If enteral nutrition is not tolerated or is not indicated, supplemental PN is used to make up the energy shortfall. The PN formula used is standard (1000 kcal/l, 37 g/l protein). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years
- Receiving PN and/or EN nutrition
- Indwelling urinary catheter
- Mechanically ventilated patients
Key exclusion criteria (6 listed)
- Age < 18 years
- Chronic renal or hepatic failure
- Current or history (past 6 months) of GI bleeding
- BMI >30 kg/m2 o <18 kg/m2
- Terminally ill patients
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 SUPPLEMENTATION | Dietary supplement | PROTEIN-FORTIFIED DIET |
Primary outcome
nitrogen balance (gr)
Time frame: change from baseline through study completion, an average of 15 days
(gr)
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 28 Apr 2021.
- Derived from this study: PubMed 28487264Danielis M, Lorenzoni G, Cavaliere L, Ruffolo M, Peressoni L, De Monte A, Muzzi R, Beltrame F, Gregori D. Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2017 May 9;6(5):e78. doi: 10.2196/resprot.7100.
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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 PROTEIN SUPPLEMENTATION in people with Protein Deficiency, run by University of Padova.
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 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: finished, as of the sponsor's last update on 28 Apr 2021. 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?
nitrogen balance (gr) (time frame: change from baseline through study completion, an average of 15 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 NCT02990065, which also lists 1 linked publication.
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 28 Apr 2021.