Dataset Information

Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial.

ABSTRACT: Nitrogen balance (NB) is considered a good marker of adequate protein intake and it has been suggested to be a good predictor of patients' health outcomes. However, in literature, there is a lack of large randomized trials examining NB-guided protein intake in patients in intensive care units (ICUs). A randomized controlled trial enrolling patients admitted to ICU was done to compare changes in NB. Participants were randomized to a standard or protein-fortified diet (protein intake of 1.8 g/kg/day according to the guidelines of the Society of Critical Care Medicine and the American Society for Parenteral and Enteral Nutrition). The primary endpoint was represented by the NB on Day 1, 3, and study exit. Forty patients were enrolled in the study (19 in the protein-fortified group). The longitudinal analysis showed that, on Day 3, patients randomized to the protein-fortified diet were more likely (p < 0.001) to present better NB (at 3 days, patients in the protein-fortified diet were estimated to have a nitrate value of 5.22 g more than patients in the standard diet, 95% CI 3.86-6.58). The protein-fortified diet was found to be significantly and directly associated with changes in NB in critically ill patients admitted to ICU.

SUBMITTER: Danielis M

PROVIDER: S-EPMC6567073 | biostudies-literature | 2019 Apr

REPOSITORIES: biostudies-literature

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Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial.

Danielis Matteo M Lorenzoni Giulia G Azzolina Danila D Iacobucci Anna A Trombini Omar O De Monte Amato A Gregori Dario D Beltrame Fabio F

Nutrients 20190428 5

Nitrogen balance (NB) is considered a good marker of adequate protein intake and it has been suggested to be a good predictor of patients' health outcomes. However, in literature, there is a lack of large randomized trials examining NB-guided protein intake in patients in intensive care units (ICUs). A randomized controlled trial enrolling patients admitted to ICU was done to compare changes in NB. Participants were randomized to a standard or protein-fortified diet (protein intake of 1.8 g/kg/d ...[more]

PMID: 31035354

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Project description:In the Fluid and Catheter Treatment Trial (NCT00281268), adults with acute lung injury randomized to a conservative vs. liberal fluid management protocol had increased days alive and free of mechanical ventilator support (ventilator-free days). Recruiting sufficient children with acute lung injury into a pediatric trial is challenging. A Bayesian statistical approach relies on the adult trial for the a priori effect estimate, requiring fewer patients. Preparing for a Bayesian pediatric trial mirroring the Fluid and Catheter Treatment Trial, we aimed to: 1) identify an inverse association between fluid balance and ventilator-free days; and 2) determine if fluid balance over time is more similar to adults in the Fluid and Catheter Treatment Trial liberal or conservative arms.Multicentered retrospective cohort study.Five pediatric intensive care units.Mechanically ventilated children (age?1 month to <18 yrs) with acute lung injury admitted in 2007-2010.None.Fluid intake, output, and net fluid balance were collected on days 1-7 in 168 children with acute lung injury (median age 3 yrs, median PaO2/FIO2 138) and weight-adjusted (mL/kg). Using multivariable linear regression to adjust for age, gender, race, admission day illness severity, PaO2/FIO2, and vasopressor use, increasing cumulative fluid balance (mL/kg) on day 3 was associated with fewer ventilator-free days (p=.02). Adjusted for weight, daily fluid balance on days 1-3 and cumulative fluid balance on days 1-7 were higher in these children compared to adults in the Fluid and Catheter Treatment Trial conservative arm (p<.001, each day) and was similar to adults in the liberal arm.Increasing fluid balance on day 3 in children with acute lung injury at these centers is independently associated with fewer ventilator-free days. Our findings and the similarity of fluid balance patterns in our cohort to adults in the Fluid and Catheter Treatment Trial liberal arm demonstrate the need to determine whether a conservative fluid management strategy improves clinical outcomes in children with acute lung injury and support a Bayesian trial mirroring the Fluid and Catheter Treatment Trial.

Project description:BackgroundNonosmotic sodium storage has been reported in animals, healthy individuals and patients with hypertension, hyperaldosteronism and end-stage kidney disease. Sodium storage has not been studied in ICU patients, who frequently receive large amounts of sodium chloride-containing fluids. The objective of our study was to estimate sodium that cannot be accounted for by balance studies in critically ill patients. Chloride was also studied. We used multiple scenarios and assumptions for estimating sodium and chloride balances.MethodsWe retrospectively analyzed patients admitted to the ICU after cardiothoracic surgery with complete fluid, sodium and chloride balance data for the first 4 days of ICU treatment. Balances were obtained from meticulously recorded data on intake and output. Missing extracellular osmotically active sodium (MES) was calculated by subtracting the expected change in plasma sodium from the observed change in plasma sodium derived from balance data. The same method was used to calculate missing chloride (MEC). To address considerable uncertainties on the estimated extracellular volume (ECV) and perspiration rate, various scenarios were used in which the size of the ECV and perspiration were varied.ResultsA total of 38 patients with 152 consecutive ICU days were analyzed. In our default scenario, we could not account for 296 ± 35 mmol of MES in the first four ICU days. The range of observed MES in the five scenarios varied from 111 ± 27 to 566 ± 41 mmol (P < 0.001). A cumulative value of 243 ± 46 mmol was calculated for MEC in the default scenario. The range of cumulative MEC was between 62 ± 27 and 471 ± 56 mmol (P = 0.001 and P = 0.003). MES minus MEC varied from 1 ± 51 to 123 ± 33 mmol in the five scenarios.ConclusionsOur study suggests considerable disappearance of osmotically active sodium in critically ill patients and is the first to also suggest rather similar disappearance of chloride from the extracellular space. Various scenarios for insensible water loss and estimated size for the ECV resulted in considerable MES and MEC, although these estimates showed a large variation. The mechanisms and the tissue compartments responsible for this phenomenon require further investigation.

Dataset Information

Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial.

Publications

Effect of Protein-Fortified Diet on Nitrogen Balance in Critically Ill Patients: Results from the OPINiB Trial.

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