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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02990065
Recruitment Status : Unknown
Verified December 2016 by Dario Gregori, University of Padova.
Recruitment status was:  Not yet recruiting
First Posted : December 12, 2016
Last Update Posted : December 12, 2016
Information provided by (Responsible Party):
Dario Gregori, University of Padova

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.

Condition or disease Intervention/treatment Phase
Protein Deficiency Dietary Supplement: PROTEIN SUPPLEMENTATION Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)
Study Start Date : December 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : June 2017

Arm Intervention/treatment
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).
No Intervention: STANDARD DIET
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).

Primary Outcome Measures :
  1. nitrogen balance (gr) [ Time Frame: change from baseline through study completion, an average of 15 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02990065

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Contact: Mariangela Ruffolo, MS +390498275646

Sponsors and Collaborators
University of Padova
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Dario Gregori, Associate Professor, University of Padova Identifier: NCT02990065    
Other Study ID Numbers: OPINiB 2016
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Keywords provided by Dario Gregori, University of Padova:
Additional relevant MeSH terms:
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Protein Deficiency
Deficiency Diseases
Nutrition Disorders