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IRCT20230809059093N1 IRCT 2023-08-19 Mashhad University of Medical Sciences Comparison of complications of two types of catheter in children undergoing Acute peritoneal dialysis Comparison of complications of conventional peritoneal catheters with nephrostomy catheter in children with acute kidney failure undergoing Acute peritoneal dialysis 2023-05-22 anticipated 50 Complete https://irct.ir/trial/71926 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization. N/A Peritoneal Dialysis. Intervention 1: Control group: In this group, infants and children (25 person) are subjected to intraperitoneal catheterization according to the type of underlying disease and the indications that require acute dialysis. The conventional method is to use a rigid catheter, which has only one size from newborn to adult, and it should be shortened for infants. This catheter can be placed in the patient's body by open surgery through the skin or laparoscopically. Intervention 2: Intervention group: In this group, a nephrostomy catheter is used for acute dialysis. Performing the intervention is the same as catheterization in the control group in terms of possible risks. (25 person). https://doi.org/10.5812/ijpediatr-164181 Background: Acute kidney injury (AKI) is a serious problem among hospitalized children and is associated with adverse outcomes. Peritoneal dialysis is the preferred modality for treating AKI in children. Nephrostomy catheters may serve as an alternative to rigid catheters, given the latter’s suboptimal design and associated complications. Objectives: This study aimed to compare catheter-related complications between nephrostomy and rigid catheters in children with AKI who required acute peritoneal dialysis. Methods: In this randomized clinical trial, children aged 0 - 12 years with AKI requiring urgent peritoneal dialysis were randomly assigned to receive either a rigid catheter (control group) or a nephrostomy catheter (intervention group). Demographic and clinical data were collected, and outcomes included catheter-related complications. Results: A total of 50 children were enrolled. Catheter leakage occurred in 28% of patients in the rigid catheter group and 20% in the nephrostomy group (odds ratio [OR] = 0.64; 95% confidence interval [CI], 0.17 - 2.38; P = 0.50). The mean duration of catheter use differed significantly between the groups, with a mean difference of 2.24 days (95% CI, 0.18 - 4.29; P = 0.02). No significant differences were observed between the 2 groups in peritonitis, exit-site infection, the need for chronic dialysis, or mortality (all P > 0.05). Conclusions: Both catheter types are feasible for acute peritoneal dialysis in children with AKI. However, because nephrostomy catheters had a significantly longer catheter survival duration, their use may offer a relative advantage in specific conditions. Multicenter studies with larger sample sizes are recommended to confirm these findings. Keywords: Nephrostomy Catheter, Acute Kidney Injury, Pediatric, Peritoneal Dialysis, Rigid Catheter Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information
public Sara Saadat
Dr. Sheikh Hospital
Mashhad Iran (Islamic Republic of) 9139963185 +98 51 3726 9021 SaadatS@mums.ac.ir Mashhad University of Medical Sciences scientific Sara Saadat
Dr. Sheikh Hospital
Mashhad Iran (Islamic Republic of) 9139963185 +98 51 3726 9021 SaadatS@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Children and infants with acute kidney failure undergoing peritoneal dialysis Children and infants between the ages of 0-12 years 1 day 12 years Both N18.5 Chronic kidney disease, stage 5 Treatment - Devices Treatment - Devices Control group: In this group, infants and children (25 person) are subjected to intraperitoneal catheterization according to the type of underlying disease and the indications that require acute dialysis. The conventional method is to use a rigid catheter, which has only one size from newborn to adult, and it should be shortened for infants. This catheter can be placed in the patient's body by open surgery through the skin or laparoscopically. Intervention group: In this group, a nephrostomy catheter is used for acute dialysis. Performing the intervention is the same as catheterization in the control group in terms of possible risks. (25 person) The primary measurable outcome is the performance of nephrostomy catheter versus acute peritoneal catheter according to age. Timepoint: Patients are examined within 1 to 20 days in terms of complications and outcomes, including spontaneous withdrawal of the catheter - catheter infection - leakage of the catheter site - lack of function - recovery of the patient - need for chronic dialysis - death despite good catheter performance. In the intervention group, a nephrostomy catheter is used for acute dialysis. Method of measurement: Observation of catheter function. Secondary measurable outcomes are peritonitis rate and fluid leakage rate in nephrostomy catheter compared to acute peritoneal catheter. Timepoint: Patients are examined within 1 to 20 days in terms of complications and outcomes, including spontaneous withdrawal of the catheter - catheter infection - leakage of the catheter site - lack of function - recovery of the patient - need for chronic dialysis - death despite good catheter performance. In the intervention group, a nephrostomy catheter is used for acute dialysis. For all cases, a culture and smear from the returned peritoneal fluid is sent from the first day, and all necessary information is recorded in terms of leakage from the catheter and malfunction or peritoneal peritonitis (the presence of white blood cells more than 100 and a positive peritoneal culture). In the case of infection, the catheter will be replaced. After collecting the data, statistical analysis will be done. Method of measurement: Culture and smear of peritoneal return fluid. Mashhad University of Medical Sciences Approved 2023-06-27 Research Ethics Committee of the Faculty of Medicine, Mashhad University of Medical Sciences Faculty of Medicine, Mashhad University of Medical Sciences, Kalantari Highway Mashhad Razavi Khorasan Iran (Islamic Republic of)