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

Sponsor

University of Padova (Other)

Overall Status

Completed

CT.gov ID

NCT02990065

Collaborator

(none)

Enrollment

Arms

20.9

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Protein Deficiency	Dietary Supplement: PROTEIN SUPPLEMENTATION	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

40 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)

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

May 31, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PROTEIN-FORTIFIED DIET 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).	Dietary Supplement: PROTEIN SUPPLEMENTATION
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).

Arm

Intervention/Treatment

Experimental: PROTEIN-FORTIFIED DIET

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).

Dietary Supplement: PROTEIN SUPPLEMENTATION

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).

Outcome Measures

Primary Outcome Measures

nitrogen balance (gr) [change from baseline through study completion, an average of 15 days]
(gr)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

University of Padova

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dario Gregori, Associate Professor, University of Padova

ClinicalTrials.gov Identifier:

NCT02990065

Other Study ID Numbers:

OPINiB 2016

First Posted:

Dec 12, 2016

Last Update Posted:

Apr 28, 2021

Last Verified:

Apr 1, 2021

Keywords provided by Dario Gregori, Associate Professor, University of Padova

PROTEIN SUPPLEMENTATION

NUTRITIONAL STATUS

Additional relevant MeSH terms:

Protein Deficiency

Study Results

No Results Posted as of Apr 28, 2021