Comparison of complications of conventional peritoneal catheters with nephrostomy catheter in children with acute kidney failure undergoing Acute peritoneal dialysis
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Trial results
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Yes
1
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2026-08-18, 1405/05/27
2026-08-18 21:40:39
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2026-05-30, 1405/03/09
2026-05-30 00:00:00
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https://doi.org/10.5812/ijpediatr-164181
https://doi.org/10.5812/ijpediatr-164181
empty
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
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
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پیشزمینه: آسیب حاد کلیه (AKI) یک مشکل جدی در میان کودکان بستری در بیمارستان است و با پیامدهای نامطلوب همراه است. دیالیز صفاقی روش ارجح برای درمان آسیب حاد کلیه در کودکان محسوب میشود. کاتترهای نفروستومی میتوانند جایگزینی برای کاتترهای سخت (Rigid) باشند؛ زیرا طراحی نامناسب کاتترهای سخت میتواند با عوارضی همراه باشد.
هدف: این مطالعه با هدف مقایسه عوارض مرتبط با کاتتر بین کاتترهای نفروستومی و کاتترهای سخت در کودکان مبتلا به آسیب حاد کلیه که به دیالیز صفاقی حاد نیاز داشتند، انجام شد.
روشها: در این کارآزمایی بالینی تصادفیشده، کودکان ۰ تا ۱۲ ساله مبتلا به آسیب حاد کلیه که نیازمند دیالیز صفاقی فوری بودند، بهصورت تصادفی در یکی از دو گروه قرار گرفتند: گروه کنترل که کاتتر سخت دریافت کردند و گروه مداخله که برای آنها کاتتر نفروستومی استفاده شد. اطلاعات جمعیتشناختی و بالینی جمعآوری شد و پیامدهای مورد بررسی شامل عوارض مرتبط با کاتتر بود.
نتایج: در مجموع ۵۰ کودک وارد مطالعه شدند. نشت از محل کاتتر در ۲۸٪ از بیماران گروه کاتتر سخت و در ۲۰٪ از بیماران گروه نفروستومی رخ داد (نسبت شانس [OR] = 0.64؛ فاصله اطمینان ۹۵٪ [CI]، 0.17 تا 2.38؛ 0.50 = P). میانگین مدت استفاده از کاتتر بین دو گروه تفاوت معناداری داشت و میانگین اختلاف آن ۲.۲۴ روز بود (فاصله اطمینان ۹۵٪، 0.18 تا 4.29؛ 0.02 = P). در بروز پریتونیت (التهاب صفاق)، عفونت محل خروج کاتتر، نیاز به دیالیز مزمن یا مرگومیر، تفاوت معناداری بین دو گروه مشاهده نشد (در همه موارد 0.05 < P).
نتیجهگیری: هر دو نوع کاتتر برای انجام دیالیز صفاقی حاد در کودکان مبتلا به آسیب حاد کلیه قابل استفاده و عملی هستند. بااینحال، از آنجا که کاتترهای نفروستومی مدت بقای کاتتر بهطور معناداری طولانیتری داشتند، استفاده از آنها ممکن است در شرایط خاص مزیت نسبی داشته باشد. برای تأیید این یافتهها، انجام مطالعات چندمرکزی با حجم نمونه بزرگتر توصیه میشود.
کلیدواژهها: کاتتر نفروستومی، آسیب حاد کلیه، کودکان، دیالیز صفاقی، کاتتر سخت
پیشزمینه: آسیب حاد کلیه (AKI) یک مشکل جدی در میان کودکان بستری در بیمارستان است و با پیامدهای نامطلوب همراه است. دیالیز صفاقی روش ارجح برای درمان آسیب حاد کلیه در کودکان محسوب میشود. کاتترهای نفروستومی میتوانند جایگزینی برای کاتترهای سخت (Rigid) باشند؛ زیرا طراحی نامناسب کاتترهای سخت میتواند با عوارضی همراه باشد. هدف: این مطالعه با هدف مقایسه عوارض مرتبط با کاتتر بین کاتترهای نفروستومی و کاتترهای سخت در کودکان مبتلا به آسیب حاد کلیه که به دیالیز صفاقی حاد نیاز داشتند، انجام شد. روشها: در این کارآزمایی بالینی تصادفیشده، کودکان ۰ تا ۱۲ ساله مبتلا به آسیب حاد کلیه که نیازمند دیالیز صفاقی فوری بودند، بهصورت تصادفی در یکی از دو گروه قرار گرفتند: گروه کنترل که کاتتر سخت دریافت کردند و گروه مداخله که برای آنها کاتتر نفروستومی استفاده شد. اطلاعات جمعیتشناختی و بالینی جمعآوری شد و پیامدهای مورد بررسی شامل عوارض مرتبط با کاتتر بود. نتایج: در مجموع ۵۰ کودک وارد مطالعه شدند. نشت از محل کاتتر در ۲۸٪ از بیماران گروه کاتتر سخت و در ۲۰٪ از بیماران گروه نفروستومی رخ داد (نسبت شانس [OR] = 0.64؛ فاصله اطمینان ۹۵٪ [CI]، 0.17 تا 2.38؛ 0.50 = P). میانگین مدت استفاده از کاتتر بین دو گروه تفاوت معناداری داشت و میانگین اختلاف آن ۲.۲۴ روز بود (فاصله اطمینان ۹۵٪، 0.18 تا 4.29؛ 0.02 = P). در بروز پریتونیت (التهاب صفاق)، عفونت محل خروج کاتتر، نیاز به دیالیز مزمن یا مرگومیر، تفاوت معناداری بین دو گروه مشاهده نشد (در همه موارد 0.05 < P). نتیجهگیری: هر دو نوع کاتتر برای انجام دیالیز صفاقی حاد در کودکان مبتلا به آسیب حاد کلیه قابل استفاده و عملی هستند. بااینحال، از آنجا که کاتترهای نفروستومی مدت بقای کاتتر بهطور معناداری طولانیتری داشتند، استفاده از آنها ممکن است در شرایط خاص مزیت نسبی داشته باشد. برای تأیید این یافتهها، انجام مطالعات چندمرکزی با حجم نمونه بزرگتر توصیه میشود. کلیدواژهها: کاتتر نفروستومی، آسیب حاد کلیه، کودکان، دیالیز صفاقی، کاتتر سخت
Protocol summary
Study aim
Determination and comparison of complications (peritonitis, temporary leakage of dialysis fluid, hernia, etc.) of rigid peritoneal catheters with nephrostomy tube in infants and children with acute kidney failure undergoing peritoneal dialysis in Dr. Sheikh and Ghaem Mashhad Hospital
Design
This research is a non-blind randomized clinical trial study that will be performed on 50 patients hospitalized in the ICU departments of Dr. Sheikh and Ghaem Mashhad Hospital during 2023, 2024 and 2025. The research includes neonates, infants and children with acute kidney failure who undergo acute peritoneal dialysis due to the indications of emergency dialysis.
Settings and conduct
Peritoneal dialysis center in the special care department for infants and children in Ghaem, Sheikh, Imam Reza and Akbar Hospitals
The number of 50 participating patients who have the study entry criteria will be placed in two groups of rigid peritoneal catheters and nephrostomy tube group by simple randomization method. Due to the nature of the study, blinding will not be performed.
Participants/Inclusion and exclusion criteria
Children and infants with acute kidney failure undergoing peritoneal dialysis between the ages of 0-12 years
Intervention groups
The intervention group includes infants and children who undergo acute peritoneal dialysis with a nephrostomy catheter, and the control group includes infants and children who undergo acute peritoneal dialysis with a rigid acute catheter.
Main outcome variables
The number of peritonitis - dialysis catheter performance - acute catheter leakage rate - patient recovery - need for chronic dialysis - death
General information
Reason for update
the sample size was entered incorrectly
Acronym
IRCT registration information
IRCT registration number:IRCT20230809059093N1
Registration date:2023-08-19, 1402/05/28
Registration timing:registered_while_recruiting
Last update:2026-08-18, 1405/05/27
Update count:2
Registration date
2023-08-19, 1402/05/28
Registrant information
Name
Yasamin Nakhaee Moghaddam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3845 4753
Email address
nakhaeimy971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
2023-05-22, 1402/03/01
Actual recruitment end date
2025-03-20, 1403/12/30
Trial completion date
2025-09-09, 1404/06/18
Scientific title
Comparison of complications of conventional peritoneal catheters with nephrostomy catheter in children with acute kidney failure undergoing Acute peritoneal dialysis
Public title
Comparison of complications of two types of catheter in children undergoing Acute peritoneal dialysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children and infants with acute kidney failure undergoing peritoneal dialysis
Children and infants between the ages of 0-12 years
Exclusion criteria:
Age
From 1 day old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the Faculty of Medicine, Mashhad University of Medical Sciences
Street address
Faculty of Medicine, Mashhad University of Medical Sciences, Kalantari Highway
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2023-06-27, 1402/04/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1402.188
Health conditions studied
1
Description of health condition studied
Peritoneal Dialysis
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
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 outcomes
1
Description
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
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
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)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Sheikh Hospital
Full name of responsible person
Yasamin Nakhaee Moghaddam
Street address
Dr. Sheikh Children's Hospital, Dr. Sheikh Street, Tohid Sq.
City
Mashhsad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
Nakhaeimy971@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Sara Saadat
Street address
Dr. Sheikh Hospital
City
Mashhsad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
Sheikh.hos@mums.ac.ir
Web page address
https://sheikh.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
SaadatS@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Sara Saadat
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Nephrology
Street address
Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
SaadatS@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Yasamin Nakhaee Moghaddam
Position
Medical Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Dr. Sheikh Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9139963185
Phone
+98 51 3726 9021
Email
Nakhaeimy971@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Trial results
Please tick if results have been published
Yes
Summary result posting date
2026-08-18, 1405/05/27
Table of baseline comparison
Participant flow diagram
Table of variable outcomes' results
Table of adverse events
First publication date
2026-05-30, 1405/03/09
Abstract of published paper
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