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Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients (OPINiB)

Primary Purpose

Protein Deficiency

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PROTEIN SUPPLEMENTATION
Sponsored by
University of Padova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Protein Deficiency focused on measuring PROTEIN SUPPLEMENTATION, NUTRITIONAL STATUS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • Age > 18 years
  • Receiving PN and/or EN nutrition
  • Indwelling urinary catheter
  • Mechanically ventilated patients

Exclusion criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    PROTEIN-FORTIFIED DIET

    STANDARD DIET

    Arm Description

    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).

    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).

    Outcomes

    Primary Outcome Measures

    nitrogen balance (gr)
    (gr)

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2016
    Last Updated
    April 26, 2021
    Sponsor
    University of Padova
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02990065
    Brief Title
    Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients
    Acronym
    OPINiB
    Official Title
    Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    May 31, 2018 (Actual)
    Study Completion Date
    September 30, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Padova

    4. Oversight

    5. Study Description

    Brief 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 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Protein Deficiency
    Keywords
    PROTEIN SUPPLEMENTATION, NUTRITIONAL STATUS

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PROTEIN-FORTIFIED DIET
    Arm Type
    Experimental
    Arm Description
    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).
    Arm Title
    STANDARD DIET
    Arm Type
    No Intervention
    Arm Description
    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).
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    PROTEIN SUPPLEMENTATION
    Primary Outcome Measure Information:
    Title
    nitrogen balance (gr)
    Description
    (gr)
    Time Frame
    change from baseline through study completion, an average of 15 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Age > 18 years Receiving PN and/or EN nutrition Indwelling urinary catheter Mechanically ventilated patients Exclusion criteria: 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

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28487264
    Citation
    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.
    Results Reference
    derived

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    Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients

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