A young age, high RACHS-1 score and CPB were independent risk factors for ARF after surgical procedures for congenital heart disease in children. The risk of ARF decreased during the study period. Children with severe ARF spent a longer time in the ICU, and the mortality in ARF patients was higher than that in non-ARF patients.
To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes.
RESEARCH DESIGN AND METHODSAfter a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart (n = 260), mealtime IAsp (n = 258), or open-label postmeal faster aspart (n = 259). The primary end point was change from baseline in glycated hemoglobin (HbA 1c ) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect.
RESULTSAt week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA 1c (P < 0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference 20.17% [95% CI 20.30; 20.03], 21.82 mmol/mol [23.28; 20.36]; P = 0.014). Change from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and over all meals (P < 0.01 for all). No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp.
CONCLUSIONSIn children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA 1c control compared with IAsp.
The present single-center cohort study was based on a clinical intensive care unit database containing data on 1128 consecutive children undergoing their first operation for congenital heart disease between 1993 and 2002 at Aarhus University Hospital, Skejby, Denmark. A total of 130 (11.5%) children developed postoperative acute renal failure (ARF) managed with peritoneal dialysis (PD). Logistic regression analysis was used to examine risk factors for complications related to PD and to compare mortality between ARF and non-ARF patients controlling for potential confounding factors. A total of 43 complications related to PD were registered in 27 (20.8%) patients. Major complications were seen in eight (6.2%) patients, and only two (1.5%) patients were switched to hemodialysis after peritonitis and hemicolectomy due to bowel perforation. The main risk factors for complications to PD were duration of PD, high RACHS-1 score (Risk Adjusted Classification for Congenital Heart Surgery), and hyperkalemia at initiation of PD. Overall, in-hospital mortality was 6.8% (76/1128). Mortality of ARF patients was 20.0% compared to 5.0% among non-ARF patients (adjusted odds ratio=1.91, 95% confidence interval=1.10-3.36). After stratification, ARF was strongly associated with increased mortality in the subgroups of patients with the lowest overall risk of dying (age> or =1 year, body weight> or =5 kg, RACHS-1 score <3, and no preoperative cyanosis). For patients at high risk of dying (age <1 year, body weight <5 kg, RACHS-1 score> or =3, cardiopulmonary bypass time> or =60 min, and preoperative cyanosis), the association between ARF and mortality was substantially weaker. In conclusion, postoperative ARF was associated with increased mortality in children operated for congenital heart disease. Major complications to PD were few, and our data strongly support that PD is a simple, safe, feasible, and robust dialysis modality for the management of ARF in children.
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