Protocol summary
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Study aim
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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
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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Children and infants with acute kidney failure undergoing peritoneal dialysis between the ages of 0-12 years
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Intervention groups
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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.
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Main outcome variables
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The number of peritonitis - dialysis catheter performance - acute catheter leakage rate - patient recovery - need for chronic dialysis - death
General information
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Reason for update
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the sample size was entered incorrectly
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Acronym
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IRCT registration information
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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
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Registration date
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2023-08-19, 1402/05/28
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2023-05-22, 1402/03/01
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Expected recruitment end date
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2025-03-20, 1403/12/30
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Actual recruitment start date
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2023-05-22, 1402/03/01
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Actual recruitment end date
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2025-03-20, 1403/12/30
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Trial completion date
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2025-09-09, 1404/06/18
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Scientific title
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Comparison of complications of conventional peritoneal catheters with nephrostomy catheter in children with acute kidney failure undergoing Acute peritoneal dialysis
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Public title
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Comparison of complications of two types of catheter in children undergoing Acute peritoneal dialysis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Children and infants with acute kidney failure undergoing peritoneal dialysis
Children and infants between the ages of 0-12 years
Exclusion criteria:
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Age
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From 1 day old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2023-06-27, 1402/04/06
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Ethics committee reference number
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IR.MUMS.MEDICAL.REC.1402.188
Health conditions studied
1
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Description of health condition studied
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Peritoneal Dialysis
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ICD-10 code
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N18.5
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ICD-10 code description
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Chronic kidney disease, stage 5
Primary outcomes
1
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Description
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The primary measurable outcome is the performance of nephrostomy catheter versus acute peritoneal catheter according to age.
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Timepoint
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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.
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Method of measurement
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Observation of catheter function
Secondary outcomes
1
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Description
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Secondary measurable outcomes are peritonitis rate and fluid leakage rate in nephrostomy catheter compared to acute peritoneal catheter.
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Timepoint
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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.
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Method of measurement
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Culture and smear of peritoneal return fluid
Intervention groups
1
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Description
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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.
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Category
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Treatment - Devices
2
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Description
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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)
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Category
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Treatment - Devices
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mashhad University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available