Cohort Multicenter Study on the Role of Medications in Parenteral Nutrition-Related Alteration of Liver Function Tests in Adults.

BACKGROUND: Our objective was to assess in non-critically-ill adult inpatients receiving parenteral nutrition (PN) the risk of developing liver function test (LFT) alterations when receiving concomitant possibly hepatotoxic medications or others reported to improve LFTs during PN. METHODS: A multicenter retrospective analysis of prospectively collected data was performed on patients receiving PN. Two groups were recruited: group LALT (patients with any LFT alterations during PN), and group NOLALT (patients without such alterations). Exclusion criteria were previous sepsis, shock, renal failure, hyperglycemia, LFT alteration, or biliopancreatic surgical procedures. Medications were classified into 2 categories: medications reported to improve LFTs during PN (n = 8) and possibly hepatotoxic medications (n = 54), including a subgroup of possibly highly hepatotoxic medications (n = 30). RESULTS: The study included 200 patients, 136 (68.0%) in the LALT group. The groups differed in the number of patients requiring surgical intervention ≤7 days before PN (LALT, 94 [69.1%]; NOLALT, 29 [45.3%]; P < .002) and those receiving possibly hepatotoxic medications (LALT, 126 [92.6%]; NOLALT, 45 [70.3%]; P < .001). Variables in the final Cox regression model were possibly hepatotoxic medications, odds ratio (OR) 3.310 (1.678-6.530); surgical intervention prior to PN, OR 1.861 (1.277-2.711); baseline triglyceridemia, OR 1.005 (1.001-1.009); and creatinine, OR 1.861 (1.043-3.323). CONCLUSIONS: Patients who received PN and concomitantly possibly hepatotoxic medications had a 3-fold risk of developing LFT alterations. Medications reported to improve LFTs had no effect. The use of possibly hepatotoxic medications during PN was associated with LFT alterations.

Análisis bioquímico como método eficiente para aumentar la seguridad de la nutrición parenteral en neonatos / Biochemical test as an efficient system to improve safety in parenteral nutrition for premature infants

Objetivo: Se describe el proceso de validación del control bioquímico de las bolsas de nutrición parenteral para verificar la correcta composición de ingredientes críticos antes de la administración, así como su impacto en la seguridad tras dos años desde la implantación en una población de recién nacidos prematuros. Método: Para la validación de la técnica se usaron 35 muestras de nutrición parenteral sin lípidos, que se procesaron en el laboratorio de Urgencias, siguiendo los procedimientos rutinarios utilizados para medir las concentraciones de glucosa y electrolitos en plasma y orina. Para analizar su impacto en la seguridad se realizaron análisis pre y post implantación mediante análisis modal de falla, efectos y criticidad. También se evaluaron los resultados fuera de rango y sus potenciales repercusiones en la seguridad del paciente. Resultados: El análisis de regresión no muestra error sistemático de medida para glucosa, calcio y potasio; en cambio, para el sodio y el magnesio sí existe un error sistemático, por lo que ambos fueron descartados para los análisis rutinarios. Los resultados del análisis modal de fallos y efectos, atribuibles a la implantación del control bioquímico, mostraron una disminución del riesgo del proceso del 11%. Se analizaron 1.734 nutriciones, correspondientes a 218 neonatos prematuros; se encontraron 58 (3,3%) resultados fuera del rango de aceptación, de los cuales 7 se consideraron errores de preparación potencialmente peligrosos. Conclusiones: El control bioquímico de glucosa y electrolitos es un método eficiente y reproducible que evita que posibles errores de preparación afecten al paciente

Objective: The biochemical test validation process of parenteral nutrition bags is described to verify the correct composition of critical compounds before its administration, as well as its impact on safety after two years since its implantation in a population of premature infants. Method: For the validation of the technique, 35 samples of parenteral nutrition without lipids were processed by the emergency laboratory, following the routine procedures used to measure the concentrations of glucose and electrolytes in plasma and urine. To analyze its impact on safety, pre-implantation and post-implantation risk analysis was carried out using failure mode, effects and criticality analysis (FMECA). Likewise, all out-of-range results and their potential repercussions on patient safety were evaluated. Results: Regression analysis showed no systematic measurement error for glucose, calcium and potassium; however, there is a constant systematic error for sodium and magnesium, thus both were discarded for routine analysis. Failure mode, effects and criticality analysis results showed a decrease in the risk of the process of 11% for the biochemical test. We tested 1,734 parenteral nutritions from 218 premature neonates; 58 (3.3%) results were out of the acceptance range, and 7 were considered to be potentially dangerous compounding errors. Conclusions: The biochemical test of glucose and electrolytes is an efficient and reproducible method that prevents possible compounding errors from reaching the patient

Biochemical test as an efficient system to improve safety in parenteral nutrition for premature infants.

OBJECTIVE: The biochemical test validation process of parenteral nutrition bags  is described to verify the correct composition of critical compounds before its  administration, as well as its impact on safety after two years since its  implantation in a population of premature infants. METHOD: For the validation of the technique, 35 samples of parenteral nutrition  without lipids were processed by the emergency laboratory, following the routine procedures used to measure the concentrations of glucose and electrolytes in  plasma and urine. To analyze its impact on safety, pre-implantation and post- implantation risk analysis was carried out using failure mode, effects and  criticality analysis (FMECA). Likewise, all out-of-range results and their potential  repercussions on patient safety were evaluated. RESULTS: Regression analysis showed no systematic measurement error for  glucose, calcium and potassium; however, there is a constant systematic error  for sodium and magnesium, thus both were discarded for routine analysis.  Failure mode, effects and criticality analysis results showed a decrease in the  risk of the process of 11% for the biochemical test. We tested 1,734 parenteral  nutritions from 218 premature neonates; 58 (3.3%) results were out of the  acceptance range, and 7 were considered to be potentially dangerous  compounding errors. CONCLUSIONS: The biochemical test of glucose and electrolytes is an efficient and reproducible method that prevents possible compounding errors from reaching  the patient.

Objetivo: Se describe el proceso de validación del control bioquímico de las  bolsas de nutrición parenteral para verificar la correcta composición de  ingredientes críticos antes de la administración, así como su impacto en la  seguridad tras dos años desde la implantación en una población de recién  nacidos prematuros.Método: Para la validación de la técnica se usaron 35 muestras de nutrición  parenteral sin lípidos, que se procesaron en el laboratorio de Urgencias,  siguiendo los procedimientos rutinarios utilizados para medir las concentraciones  de glucosa y electrolitos en plasma y orina. Para analizar su  impacto en la seguridad se realizaron análisis pre y post implantación mediante  análisis modal de falla, efectos y criticidad. También se evaluaron los resultados  fuera de rango y sus potenciales repercusiones en la seguridad del paciente.Resultados: El análisis de regresión no muestra error sistemático de medida  para glucosa, calcio y potasio; en cambio, para el sodio y el magnesio sí existe  un error sistemático, por lo que ambos fueron descartados para los análisis  rutinarios. Los resultados del análisis modal de fallos y efectos, atribuibles a la  implantación del control bioquímico, mostraron una disminución del riesgo del  proceso del 11%. Se analizaron 1.734 nutriciones, correspondientes a 218  neonatos prematuros; se encontraron 58 (3,3%) resultados fuera del rango de  aceptación, de los cuales 7 se consideraron errores de preparación  potencialmente peligrosos.Conclusiones: El control bioquímico de glucosa y electrolitos es un método  eficiente y reproducible que evita que posibles errores de preparación afecten al  paciente.

Multicenter study of parenteral nutrition in non-critically ill elderly patients compared to younger patients - Study IAIOS-PN (Incidence and Assessment of Iatrogenesis in Older Subjects receiving Parenteral Nutrition).

OBJECTIVE: this study assessed the incidence of hyperglycemia, hypertriglyceridemia, and liver function test (LFT) alterations among patients older and younger than 65 years receiving parenteral nutrition (PN). A secondary objective was to compare the incidence of any of these three events. MATERIAL AND METHODS: inclusion criteria were non-critically ill adult inpatients receiving PN for ≥ 7 days in 15 hospitals in Spain. Exclusion criteria were hyperglycemia, hypertriglyceridemia, LFT alterations, sepsis, shock, pancreatic/hepatobiliary surgery, renal failure, diabetes mellitus (DM) type 1, insulin-treated DM type 2, acute DM complications, or obesity prior to PN. Patients were classified into groups YOUNG (aged 35-64) and OLD (aged 65-95). RESULTS: this study recruited 200 patients. Group YOUNG included 63 (31.5%) patients and OLD, 137 (68.5%). Hyperglycemia appeared in 37 (18.5%) patients, eight (12.7%) in group YOUNG and 29 (21.2%) in group OLD (p = 0.174). Hypertriglyceridemia appeared in only one (0.7%) patient. LFT alterations appeared in 141 (70.5%) patients, 44 (69.8%) in group YOUNG and 97 (70.8%) in group OLD (p = 1.000). The model for hyperglycemia included DM type 2, previous surgical procedure, and use of hyperglycemia-inducing medications. The model for LFT alteration included previous surgical procedure, amount of lipids and amino acids, medications causing LFT alterations and a trend for age group. The model for any event included surgical procedure, DM type 2, and medications causing alterations. CONCLUSION: patients of ≥ 65 years receiving PN had similar incidences of hyperglycemia, hypertriglyceridemia, and LFT alterations as younger patients. Additionally, older patients had trends toward lower LFT alterations.

Multicenter study of parenteral nutrition in non-critically ill elderly patients compared to younger patients - Study IAIOS-PN (Incidence and Assessment of Iatrogenesis in Older Subjects receiving Parenteral Nutrition) / Estudio multicéntrico de nutrición parenteral en pacientes ancianos no críticos comparados con pacientes más jóvenes - Estudio IAIOS-PN (Incidencia y Valoración de Yatrogenia en Sujetos Ancianos que reciben Nutrición Parenteral)

Objective: this study assessed the incidence of hyperglycemia, hypertriglyceridemia, and liver function test (LFT) alterations among patients older and younger than 65 years receiving parenteral nutrition (PN). A secondary objective was to compare the incidence of any of these three events. Material and methods: inclusion criteria were non-critically ill adult inpatients receiving PN for ≥ 7 days in 15 hospitals in Spain. Exclusion criteria were hyperglycemia, hypertriglyceridemia, LFT alterations, sepsis, shock, pancreatic/hepatobiliary surgery, renal failure, diabetes mellitus (DM) type 1, insulin-treated DM type 2, acute DM complications, or obesity prior to PN. Patients were classified into groups YOUNG (aged 35-64) and OLD (aged 65-95). Results: this study recruited 200 patients. Group YOUNG included 63 (31.5%) patients and OLD, 137 (68.5%). Hyperglycemia appeared in 37 (18.5%) patients, eight (12.7%) in group YOUNG and 29 (21.2%) in group OLD (p = 0.174). Hypertriglyceridemia appeared in only one (0.7%) patient. LFT alterations appeared in 141 (70.5%) patients, 44 (69.8%) in group YOUNG and 97 (70.8%) in group OLD (p = 1.000). The model for hyperglycemia included DM type 2, previous surgical procedure, and use of hyperglycemia-inducing medications. The model for LFT alteration included previous surgical procedure, amount of lipids and amino acids, medications causing LFT alterations and a trend for age group. The model for any event included surgical procedure, DM type 2, and medications causing alterations. Conclusion: patients of ≥ 65 years receiving PN had similar incidences of hyperglycemia, hypertriglyceridemia, and LFT alterations as younger patients. Additionally, older patients had trends toward lower LFT alterations

Objetivo: valorar la incidencia de hiperglicemia, hipertrigliceridemia y alteraciones de los parámetros bioquímicos hepáticos (PBH) en pacientes mayores de 65 años frente a pacientes más jóvenes con nutrición parenteral (NP). El objetivo secundario fue comparar la incidencia de cualquiera de los tres eventos. Material y métodos: se incluyeron adultos no críticos hospitalizados que recibieron NP durante siete días o más en 15 hospitales españoles. Se excluyeron pacientes con hiperglicemia, hipertrigliceridemia, alteración de los PBH, sepsis, shock, cirugía biliopancreática, insuficiencia renal, diabetes tipo 1 o tipo 2 insulinodependiente, complicaciones diabéticas agudas y obesidad previas a la NP. Los pacientes se clasificaron en dos grupos: YOUNG (35-64 años) y OLD (65-95 años). Resultados: se incluyeron 200 pacientes; 63 (31,5%) en el grupo YOUNG y 137 (68,5%) en el OLD. Se detectó hiperglicemia en 37 (18,5%) pacientes, ocho (12,7%) en el grupo YOUNG y 29 (21,2%) en el OLD (p = 0,174). Solo hubo un caso (0,7%) de hipertrigliceridemia. Alteraciones de PBH aparecieron en 141 (70,5%) pacientes, 44 (69,8%) en el grupo YOUNG y 97 (70,8%) en el OLD (p = 1,000). El modelo para hiperglicemia incluyó como variables diabetes tipo 2, cirugía previa y el uso de medicamentos hiperglucemiantes. El modelo para alteración de PBH incluyó cirugía previa, dosis de lípidos y aminoácidos y medicaciones hepatotóxicas. Hubo una tendencia a menor alteración por la edad. El modelo global para cualquier evento incluyó cirugía previa, diabetes tipo 2 y medicaciones que causen las alteraciones estudiadas. Conclusión: los pacientes de 65 años o más que recibieron NP tuvieron incidencias similares de hiperglicemia, hipertrigliceridemia y alteración de PBH a las de los pacientes más jóvenes. Hubo una tendencia a menor alteración de PBH en los pacientes mayores