ArticleJMIR research protocols2017
Optimizing Protein Intake and Nitrogen Balance (OPINiB) in Adult Critically Ill Patients: A Study Protocol for a Randomized Controlled Trial.
Article in JMIR research protocols, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02990065 (Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients), which is not on this map. Cited by 4 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Optimizing Protein Intake and Nitrogen Balance in Adult Critically Ill Patients: a Randomized Controlled Trial (OPINiB STUDY)
Who cites it
4 citing papers in PubMed.
- Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial.Nutrients · 2019Trial
- Peripheral Parenteral Nutrition and Personalized Nutritional Approach After Colorectal Resection Surgery: A Comprehensive Review of Current Evidence.Medicina (Kaunas, Lithuania) · 2025Review
- Nutritional Challenges in Hemodialysis: Managing Protein Energy Wasting While Controlling Phosphorus.Clinical case reports · 2025Article
- The Impact of Bariatric Surgery on Nitrogen Balance at Six months Post-surgery.Obesity surgery · 2024Article
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAdequate nutrition of critically ill patients plays a key role in the modulation of metabolic response to stress.
objectiveThis paper presents the development of a protocol for a randomized controlled trial (RCT) aimed at comparing clinical outcomes of patients in the intensive care unit (ICU) administered with standard and protein-fortified diet. Together with the RCT study protocol, the results of the observational analysis conducted to assess the feasibility of the RCT are presented.
methodsAn RCT on adult patients admitted to ICU and undergoing mechanical ventilation in the absence of renal or hepatic failure will be conducted. Patients enrolled will be randomized with an allocation rate of 1:1 at standard diet versus protein-fortified diet. The estimated sample size is 19 per arm, for a total of 38 patients to be randomized.
resultsEnrollment began in January 2017. In the feasibility study, 14 patients were enrolled. Protein administration increased significantly (P<.001) over time but was significantly lower compared to that recommended (P<.001). Blood urea nitrogen significantly increased (P<.03) over the period of observation. Such increased catabolism resulted in negative cumulative nitrogen balance (NB) in all patients, and some patients presented with a more negative NB compared to the others.
conclusionsResults of the feasibility study clearly confirmed that protein provision in ICU patients is below that recommended and that this results in impaired NB. The emerging of an interindividual variability in NB will be further analyzed in the RCT.
trial registrationClinicalTrials.gov NCT02990065; https://clinicaltrials.gov/ct2/show/NCT02990065 (Archived by WebCite at http://www.webcitation.org/6prsqZdRM).
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