Trial reportCritical care (London, England)2026
Increased ureagenesis revealing metabolic intolerance to enhanced nutrition in the PICU: a secondary analysis of the PEPaNIC RCT.
Trial report in Critical care (London, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01536275 (Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients), which is not on this map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients
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6 authors.
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Abstract
backgroundAs compared with withholding parenteral nutrition (PN) for one week (late-PN), early supplementation of insufficient enteral nutrition with PN (early-PN) increased infection risk and delayed recovery of critically ill children in the PEPaNIC-RCT, with harm attributed to higher amino acid doses. We hypothesized that this harm could be explained by increased ureagenesis, revealing metabolic intolerance to enhanced feeding.
methodsThis is a secondary analysis of the PEPaNIC-RCT (ClinicalTrials.gov-NCT01536275), in which patients (newborn-17 years) admitted to pediatric intensive care units (PICUs, Leuven-Rotterdam-Edmonton) were randomly allocated to early-PN or late-PN. For patients not receiving renal replacement therapy (RRT), we documented plasma/serum urea and urea/creatinine ratio (UCR) profiles throughout two PICU weeks and investigated whether an increased maximum value in the randomized intervention window (first week) statistically explained harm by early-PN, via multivariable logistic regression and Cox proportional hazards analyses. We studied risk of new infections and duration of PICU dependency as primary outcomes, 90-day mortality as safety outcome, and duration of hospital dependency as secondary outcome.
resultsOf 1440 PEPaNIC-patients recruited, 665 early-PN and 663 late-PN non-RRT patients had UCR data. Urea concentrations and UCRs were higher in early-PN than in late-PN patients throughout the first 11 days. Higher first week maximum UCR independently associated with (OR/HR expressed per 30 age-normalized units) an increased risk of new infection [adjusted OR (95%CI) 1.746 (1.353-2.265), p < 0.0001], lower likelihood of earlier live PICU [adjusted HR 0.745 (0.671-0.824), p < 0.0001] and hospital discharge [adjusted-HR 0.778 (0.703-0.860), p < 0.0001], and increased 90-day mortality [adjusted OR 1.432 (1.029-1.993), p = 0.033], and statistically explained (part of) any effect of the randomized intervention. Similar results were obtained for urea concentrations.
conclusionsIncreased plasma/serum urea or UCR with early-PN partially explained the harm by early-PN, suggesting these may identify critically ill children metabolically intolerant to enhanced nutrition. This opens perspectives for incorporating urea or UCR into a dynamic monitoring tool to guide the appropriate timing and dosing of nutritional support.
trial registrationClinicalTrials.gov NCT01536275, registered February 2012.
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