Stress ulcer prophylaxis for critically ill children: routine use needs to be re-examined.

INTRODUCTION: Stress ulcer prophylaxis (SUP) is commonly used in Paediatric Intensive Care Units (PICUs). However, strong evidence for this practice is lacking and there is a dire need for paediatric randomized controlled trials (RCTs). Our aim was to assess the usefulness of SUP with omeprazole in critically ill children. PATIENTS AND METHODS: We conducted a randomized, controlled open-label trial, including 144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16. We randomly allocated patients to SUP with omeprazole or no SUP. The primary outcome was development of upper gastrointestinal bleeding or nosocomial infection. RESULTS: The incidence of gastrointestinal bleeding was 27.1%, but clinically significant bleeding developed in only 5.6% of patients. We did not find a significant difference in the incidence of bleeding between the prophylaxis and control groups (27.8% vs 26.4%; P = .85). We also did not find a significant difference between the groups in the incidence of ventilator-associated pneumonia (VAP) (9.6% vs 8.3%; P = .77). The incidence of central line-associated bloodstream infection (CLABSI) was higher in the prophylaxis group compared to the control group (30.6% vs 12.5%; P = .014). None of the patients developed Clostridium difficile-associated diarrhoea. We did not find significant differences in mortality, length of PICU stay or duration of mechanical ventilation. Mechanical ventilation was an independent predictor of bleeding (OR, 6.4; 95%CI, 2.73-14.9). CONCLUSION: In PICU patients with mild to moderate organ dysfunction, omeprazole does not seem to be useful for prevention of gastrointestinal bleeding while at the same time increasing the risk of CLABSI. Thus, we recommend restricting SUP to mechanically ventilated children.

Profilaxis de las úlceras de estrés en niños críticos: necesidad de replantear su uso rutinario / Stress ulcer prophylaxis for critically ill children: Routine use needs to be re-examined

Introducción:La profilaxis de las úlceras por estrés (PUE) se utiliza comúnmente en las Unidades de Cuidados Intensivos Pediátricos (PICU). Sin embargo, no hay pruebas sólidas que apoyen esta práctica y se necesitan urgentemente ensayos clínicos controlados aleatorios (ECCA) pediátricos. Nuestro objetivo fue evaluar el valor de la PUE con omeprazol en pacientes críticos pediátricos.Pacientes y métodos:Ensayo controlado aleatorizado abierto, con inclusión de 144 niños ingresados en la UCI con una puntuación en la escala pediátrica de evaluación del fallo multiorgánico secuencial (pSOFA) inferior a 16. Los pacientes fueron asignados al azar a recibir omeprazol para el PUE o a no recibir profilaxis. La variable de resultado principal fue el desarrollo de hemorragia digestiva alta o infecciones nosocomiales.Resultados:La frecuencia de hemorragia gastrointestinal fue del 27,1%, aunque solo desarrollaron hemorragia clínicamente significativa el 5,6% de los pacientes. No se observaron diferencias significativas en la incidencia de hemorragia entre los grupos de profilaxis y de control (27,8 vs. 26,4%; p = 0,85). Tampoco surgieron diferencias significativas en la incidencia de la neumonía asociada al ventilador (NAV) entre ambos grupos (9,6 vs. 8,3%; p = 0,77). La incidencia de bacteriemia asociada a catéter venoso central (BACVC) fue mayor en el grupo de profilaxis en comparación con el grupo de control (30,6 vs. 12,5%; p = 0,014). Ningún paciente desarrolló diarrea por Clostridium difficile. No se encontraron diferencias significativas en la tasa de mortalidad, la duración de la estancia en la UCIP o la duración de la ventilación mecánica. La ventilación mecánica fue un predictor independiente de hemorragia (OR 6,4; IC 95%: 2,73-14,9). (AU)

Introduction:Stress ulcer prophylaxis (SUP) is commonly used in Paediatric Intensive Care Units (PICUs). However, strong evidence for this practice is lacking and there is a dire need for paediatric randomized controlled trials (RCTs). Our aim was to assess the usefulness of SUP with omeprazole in critically ill children.Patients and methods:We conducted a randomized, controlled open-label trial, including 144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16. We randomly allocated patients to SUP with omeprazole or no SUP. The primary outcome was development of upper gastrointestinal bleeding or nosocomial infection. Results:The incidence of gastrointestinal bleeding was 27.1%, but clinically significant bleeding developed in only 5.6% of patients. We did not find a significant difference in the incidence of bleeding between the prophylaxis and control groups (27.8 vs. 26.4%; p = 0.85). We also did not find a significant difference between the group in the incidence of ventilator-associated pneumonia (VAP) (9.6 vs. 8.3%; p = 0.77). The incidence of central line-associated bloodstream infection (CLABSI) was higher in the prophylaxis group compared to the control group (30.6% vs. 12.5%; p = 0.014). None of the patients developed Clostridium difficile-associated diarrhoea. We did not find significant differences in mortality, length of PICU stay or duration of mechanical ventilation. Mechanical ventilation was an independent predictor of bleeding (OR 6.4; 95% CI, 2.73-14.9). (AU)

[Stress ulcer prophylaxis for critically ill children: Routine use needs to be re-examined]. / Profilaxis de las úlceras de estrés en niños críticos: necesidad de replantear su uso rutinario.

INTRODUCTION: Stress ulcer prophylaxis (SUP) is commonly used in Paediatric Intensive Care Units (PICUs). However, strong evidence for this practice is lacking and there is a dire need for paediatric randomized controlled trials (RCTs). Our aim was to assess the usefulness of SUP with omeprazole in critically ill children. PATIENTS AND METHODS: We conducted a randomized, controlled open-label trial, including 144 children admitted into a PICU with a paediatric Sequential Organ Failure Assessment (pSOFA) score of less than 16. We randomly allocated patients to SUP with omeprazole or no SUP. The primary outcome was development of upper gastrointestinal bleeding or nosocomial infection. RESULTS: The incidence of gastrointestinal bleeding was 27.1%, but clinically significant bleeding developed in only 5.6% of patients. We did not find a significant difference in the incidence of bleeding between the prophylaxis and control groups (27.8 vs. 26.4%; p = 0.85). We also did not find a significant difference between the group in the incidence of ventilator-associated pneumonia (VAP) (9.6 vs. 8.3%; p = 0.77). The incidence of central line-associated bloodstream infection (CLABSI) was higher in the prophylaxis group compared to the control group (30.6% vs. 12.5%; p = 0.014). None of the patients developed Clostridium difficile-associated diarrhoea. We did not find significant differences in mortality, length of PICU stay or duration of mechanical ventilation. Mechanical ventilation was an independent predictor of bleeding (OR 6.4; 95% CI, 2.73-14.9). CONCLUSION: In PICU patients with mild to moderate organ dysfunction, omeprazole does not seem to be useful for prevention of gastrointestinal bleeding while at the same time increasing the risk of CLABSI. Thus, we recommend restricting SUP to mechanically ventilated children.