Intravenous iron supplementation in children on hemodialysis.

Item does not contain fulltextBACKGROUND: Children with end-stage renal disease (ESRD) on hemodialysis (HD) are often absolute or functional iron deficient. There is little experience in treating these children with intravenous (i.v.) iron-sucrose. In this prospective study, different i.v. iron-sucrose doses were tested in children with ESRD on HD and the effect on iron status measured. METHODS: Fourteen patients were divided into three groups according to their actual iron status. Group A--iron deficient (ferritin (F) or =20%, or TSAT>50%). These patients received 0.3 mg/kg/dialysis iron-sucrose. Group C--possible iron-overloaded (F>400 microg/L). These patients were not treated with iron. RESULTS: Group A--3 mg/kg/dialysis of iron-sucrose resulted in a major increase in F, indicating possible iron overload. Therefore, the iron-deficient patients received 1 mg/kg/dialysis iron-sucrose during 22 periods of 2-14 (mean 5) weeks: the median F increased from 186 to 343 microg/L (p<0.001). Group B--0.3 mg/kg/dialysis iron-sucrose resulted in adequate iron levels during 22 periods of 2-60 (mean 9) weeks. CONCLUSION: In children, 3 mg/kg/dialysis iron-sucrose complex results in a possible iron overload. Dosage of 1 mg/kg/dialysis and 0.3 mg/kg/dialysis seem adequate for correction and maintenance therapy respectively

Study protocol for a parallel-group randomized controlled multi-center trial evaluating the additional effect of continuous ultrasound bladder monitoring in urotherapy for children with functional daytime urinary incontinence (SENS-U trial)

Background: Lower urinary tract dysfunction or functional urinary incontinence is a common condition with a prevalence up to 21% between 6 and 8 year-old children. It is associated with an impaired quality of life, lower self-esteem, and social stigmatization. Urotherapy is the first treatment of choice for functional daytime urinary incontinence (DUI) in children. Alarm therapy can be a part of urotherapy as it provides the child adequate feedback on wetting accidents. Current alarm systems notify either at a set interval or give a notification when wetting has already occurred to prompt the child to go to the toilet. These alarms do not teach the child the interpretation of the bladder sensation preceding wetting accidents. A new wearable bladder sensor, the SENS-U, recently became available. This is a relative small, wireless ultrasonic sensor, which continuously monitors bladder filling. The SENS-U is able to provide an alarm at the exact moment voiding is warranted. It facilitates the child to learn the sensation of bladder filling preceding voiding in an easier way, increasing the learning curve throughout treatment. Its additional effect in urotherapy on continence and cost-effectiveness is to be determined. Methods/design: This is a multi-center clinical superiority parallel-group randomized controlled trial including a total of 480 children. Participants between 6 and 16 years of age with functional DUI in which urotherapy is offered as the next treatment of choice are eligible. Four centers, two academic hospitals, and two general care (peripheral) centers are participating. Participants will be randomized at a 1:1:1 ratio into three groups: urotherapy (care as usual), urotherapy with the SENS-U added for 3 consecutive weeks throughout the training, or urotherapy with a SHAM device for 3 weeks. The primary outcome is number of wetting accidents per week after 3 months of training, compared between the SENS-U and the SHAM device. The magnitude of the placebo effect will be assessed by comparing the results of the SHAM group versus the control (care as usual) group. Discussion: To our knowledge, this is the first trial studying not only the effect but also the cost-effectiveness of alarm interventions as commonly added in urotherapy. Trial registration: ISRCTN44345202