Comparison of complications of conventional peritoneal catheters with nephrostomy catheter in children with acute kidney failure undergoing Acute peritoneal dialysis
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Protocol summary
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 Mashhad Hospital
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
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
تعیین و مقایسه عوارض(پریتونیت ، نشت موقت مایع دیالیز، هرنی و غیره) کاتترهای صفاقی ریجید با لوله نفروستومی در شیرخواران و کودکان مبتلا به نارسایی حاد کلیه تحت دیالیز صفاقی در بیمارستان دکتر شیخ مشهد
تعیین و مقایسه عوارض(پریتونیت ، نشت موقت مایع دیالیز، هرنی و غیره) کاتترهای صفاقی ریجید با لوله نفروستومی در شیرخواران و کودکان مبتلا به نارسایی حاد کلیه تحت دیالیز صفاقی در بیمارستان دکتر شیخ و قائم مشهد
تعیین و مقایسه عوارض(پریتونیت ، نشت موقت مایع دیالیز، هرنی و غیره) کاتترهای صفاقی ریجید با لوله نفروستومی در شیرخواران و کودکان مبتلا به نارسایی حاد کلیه تحت دیالیز صفاقی در بیمارستان دکتر شیخ و قائم مشهد
This research is a non-blind randomized clinical trial study that will be performed on 30 patients hospitalized in the ICU departments of Dr. Sheikh Mashhad Hospital during 2023 and 2024. The research includes infants and children with acute kidney failure who undergo acute peritoneal dialysis in Sheikh Mashhad Hospital due to the indications of emergency dialysis.
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.
This research is a non-blind randomized clinical trial study that will be performed on 3050 patients hospitalized in the ICU departments of Dr. Sheikh and Ghaem Mashhad Hospital during 2023, 2024 and 20242025. The research includes neonates, infants and children with acute kidney failure who undergo acute peritoneal dialysis in Sheikh Mashhad Hospital due to the indications of emergency dialysis.
این پژوهش یک مطالعه کارآزمایی بالینی تصادفی کور نشده می باشد که بر روی 30 بیمار بستری در بخش های ای سی یو دکتر شیخ مشهد در سال 1402 و 1403 انجام خواهد شد. جامعه پژوهش شامل شیرخواران و کودکان مبتلا به نارسایی حاد کلیه می باشد که به دلیل اندیکاسیون های دیالیز اورژانس تحت دیالیز صفاقی حاد در بیمارستان شیخ مشهد قرار می گیرند.
این پژوهش یک مطالعه کارآزمایی بالینی تصادفی کور نشده می باشد که بر روی 50 بیمار بستری در بخش های ای سی یو دکتر شیخ و قائم مشهد در سال 1402 و 1403 انجام خواهد شد. جامعه پژوهش شامل نوزادان ، شیرخواران و کودکان مبتلا به نارسایی حاد کلیه می باشد که به دلیل اندیکاسیون های دیالیز اورژانس تحت دیالیز صفاقی حاد قرار می گیرند.
این پژوهش یک مطالعه کارآزمایی بالینی تصادفی کور نشده می باشد که بر روی 3050 بیمار بستری در بخش های ای سی یو دکتر شیخ و قائم مشهد در سال 1402 و 1403 انجام خواهد شد. جامعه پژوهش شامل نوزادان ، شیرخواران و کودکان مبتلا به نارسایی حاد کلیه می باشد که به دلیل اندیکاسیون های دیالیز اورژانس تحت دیالیز صفاقی حاد در بیمارستان شیخ مشهد قرار می گیرند.
Peritoneal dialysis center in the special care department for infants and children in Ghaem, Sheikh, Imam Reza and Akbar Hospitals
The number of 30 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.
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.
Peritoneal dialysis center in the special care department for infants and children in Ghaem, Sheikh, Imam Reza and Akbar Hospitals The number of 3050 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.
بیمارستان های قائم، شیخ، امام رضا و اکبر / مرکز دیالیز صفاقی در بخش مراقبت های ویژه نوزاد و کودک
تعداد 30 بیمار شرکت کننده که معیارهای ورود به مطالعه را داشته باشند به روش تصادفی سازی ساده در دو گروه کاتتر صفاقی ریجید و گروه لوله نفروستومی قرار خواهد گرفت. به دلیل ماهیت مطالعه، کورسازی انجام نخواهد شد.
بیمارستان های قائم، شیخ، امام رضا و اکبر / مرکز دیالیز صفاقی در بخش مراقبت های ویژه نوزاد و کودک
تعداد 50 بیمار شرکت کننده که معیارهای ورود به مطالعه را داشته باشند به روش تصادفی سازی ساده در دو گروه کاتتر صفاقی ریجید و گروه لوله نفروستومی قرار خواهد گرفت. به دلیل ماهیت مطالعه، کورسازی انجام نخواهد شد.
بیمارستان های قائم، شیخ، امام رضا و اکبر / مرکز دیالیز صفاقی در بخش مراقبت های ویژه نوزاد و کودک تعداد 3050 بیمار شرکت کننده که معیارهای ورود به مطالعه را داشته باشند به روش تصادفی سازی ساده در دو گروه کاتتر صفاقی ریجید و گروه لوله نفروستومی قرار خواهد گرفت. به دلیل ماهیت مطالعه، کورسازی انجام نخواهد شد.
General information
Month
Day
monthday
30
50
3050
empty
50
50
2024-05-21, 1403/03/01
2025-03-20, 1403/12/30
20242025-0503-2120 00:00:00
empty
2023-05-22, 1402/03/01
2023-05-22 00:00:00
empty
2025-03-20, 1403/12/30
2025-03-20 00:00:00
empty
2025-09-09, 1404/06/18
2025-09-09 00:00:00
empty
the sample size was entered incorrectly
the sample size was entered incorrectly
empty
حجم نمونه به اشتباه وارد شده بود
حجم نمونه به اشتباه وارد شده بود
Intervention groups
#1
Control group: In this group, infants and children 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.
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.
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.
گروه کنترل: در این گروه شیرخواران و کودکان با توجه به نوع بیماری زمینه ای و اندیکاسیون های ذکر شده که نیاز به دیالیز حاد دارند، تحت کاتتر گذاری داخل صفاقی قرار می گیرند. روش مرسوم استفاده از کاتتر ریجید می باشد که تک سایز است و از نوزادی تا بزرگسالی یک سایز دارد و برای نوزادان باید کوتاه شود. این کاتتر را می توان به روش جراحی باز از طریق پوست یا به روش لاپاراسکوپی در بدن بیمار قرار داد.
گروه کنترل: در این گروه شیرخواران و کودکان (25 نفر ) با توجه به نوع بیماری زمینه ای و اندیکاسیون های ذکر شده که نیاز به دیالیز حاد دارند، تحت کاتتر گذاری داخل صفاقی قرار می گیرند. روش مرسوم استفاده از کاتتر ریجید می باشد که تک سایز است و از نوزادی تا بزرگسالی یک سایز دارد و برای نوزادان باید کوتاه شود. این کاتتر را می توان به روش جراحی باز از طریق پوست یا به روش لاپاراسکوپی در بدن بیمار قرار داد.
گروه کنترل: در این گروه شیرخواران و کودکان (25 نفر ) با توجه به نوع بیماری زمینه ای و اندیکاسیون های ذکر شده که نیاز به دیالیز حاد دارند، تحت کاتتر گذاری داخل صفاقی قرار می گیرند. روش مرسوم استفاده از کاتتر ریجید می باشد که تک سایز است و از نوزادی تا بزرگسالی یک سایز دارد و برای نوزادان باید کوتاه شود. این کاتتر را می توان به روش جراحی باز از طریق پوست یا به روش لاپاراسکوپی در بدن بیمار قرار داد.
#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.
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)
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)
گروه مداخله: در این گروه برای دیالیز حاد از کاتتر نفروستومی استفاده می شود. انجام مداخله از نظر خطرات احتمالی با انجام کاتتر گذاری در گروه شاهد یکسان است .
گروه مداخله: در این گروه برای دیالیز حاد از کاتتر نفروستومی استفاده می شود. انجام مداخله از نظر خطرات احتمالی با انجام کاتتر گذاری در گروه شاهد یکسان است . (25 نفر )
گروه مداخله: در این گروه برای دیالیز حاد از کاتتر نفروستومی استفاده می شود. انجام مداخله از نظر خطرات احتمالی با انجام کاتتر گذاری در گروه شاهد یکسان است . (25 نفر )
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:2025-04-20, 1404/01/31
Update count:1
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