Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201801003005742 Date of Approval: 24/01/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Gravity assisted continuous flow peritoneal dialysis in children with acute renal failure
Official scientific title Gravity assisted continuous flow peritoneal dialysis in children with acute renal failure
Brief summary describing the background and objectives of the trial Peritoneal dialysis (PD)is still the most commonly used form of dialysis used in acute kidney injury worldwide in children. Specifically, in low to middle income countries where it is often the only form of dialysis available for children with acute kidney injury. One of the criticisms of PD is the lower clearance (toxin removal) and ability for ultrafiltration (taking fluid off the patient)These issues may become important in certain cases of acute renal failure. Continuous flow peritoneal dialysis(CFPD) is a way of doing peritoneal dialysis where instead of the fluid being allowed to dwell in the peritoneal cavity and then intermittently removed, it is allowed to flow continuously through the peritoneal cavity by using two peritoneal dialysis catheters. In this way diffusion gradients are optimised and dialysis time is increased. We developed a novel technique over the past few years at Red Cross Children¿s hospital of doing CFPD in children with acute renal failure. This was very effective and vastly increasing clearance and ultrafiltration. These studies have been published in the international literature. The technique we used involved high speed pumps to drive the fluid. These pumps are expensive and so limited this technique being rolled out into low income countries where it would be the most useful. In this current study we will use a technique of CFPD using just low cost tubing and fluid and just gravity to drive fluid flow. This technique has been extensively tested in vitro an shown to be safe. Our primary objectives in this study will be compare CFPD to conventional PD in terms of efficacy complications and costs in children with acute kidney injury. The study design is a prospective randomized cross-over study.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Acute kidney injury,Injury, Occupational Diseases, Poisoning,Kidney Disease,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/02/2018
Actual trial start date 01/01/2018
Anticipated date of last follow up 01/02/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
HREC REF 363/2017 Human research ethics committee, university of Cape Town
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomization using a randomisation table created by a computer software program Not possible as the type of dialysis used is immediately evident to the investigators and allocators Masking/blinding used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomization using a randomisation table created by a computer software program Not possible as the type of dialysis used is immediately evident to the investigators and allocators Masking/blinding used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomization using a randomisation table created by a computer software program Not possible as the type of dialysis used is immediately evident to the investigators and allocators Masking/blinding used
Crossover: all participants receive all interventions in different sequence during study Randomised simple randomization using a randomisation table created by a computer software program Not possible as the type of dialysis used is immediately evident to the investigators and allocators Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Conventional peritoneal dialysis 20ml/kg of dialysis fluid per one and a half hour cycle 24 hours Conventional peritoneal dialysis 20 Active-Treatment of Control Group
Experimental Group continuous flow peritoneal dialysis 5 litres of dialysis fluid 24 hours continuous flow peritoneal dialysis 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Paediatric patients 1 day to 5 years of age in ICU setting Biochemical criteria of acute kidney injury (AKI): according to the Kidney Injury score (KDIGO) criteria The decision to start acute dialysis will be made based on the biochemical criteria and the clinical opinion of the pediatric nephrologists and the ICU consultants Clinical condition contraindicates procedure of catheter placement PD. E.g. abdominal wall defects, severe diaphragmatic defects, burns or septic skin lesions covering the whole abdominal wall. Peritonitis only if the catheter is not able to be placed safely. 1 Day(s) 5 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 28/08/2017 University of Cape Town, Faculty of Health Sciences, Human research ethics committee
Ethics Committee Address
Street address City Postal code Country
Room E53-46 Old Main Building, Groote Schuur Hospital, Main Road Observatory Cape Town 7924 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Clearance of : Urea, creatinine, phosphate, potassium, albumin expressed ml/min/1.73 m2 and KT/V(clearance divided by total body water) 24 hours 48 hours
Primary Outcome Total ultra-filtration rate measured in ml/kg per hour 24 hours 48 hours
Secondary Outcome Mass transport area co-efficient 24 hours 48 hours
Secondary Outcome glucose absorption 24 hours 48hours
Secondary Outcome Protein loss in grams 24 hours 48 hours
Secondary Outcome dialysate salt removal 24 hours 48 hours
Secondary Outcome Free water transport 24 hours 48 hours
Secondary Outcome intraperitoneal pressure at start of intervention At start of control
Secondary Outcome cost comparison between intervention and control At end of intervention At end of control
Secondary Outcome complications At end of intervention period At end of control period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Red Cross War Memmorial Children's Hospital Klipfontein Road, Rondebosch Cape Town 7700 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of cape town renal research fund Red Cross War memmorial Childrens Hospital , Klipfontein Road, Rondebosch Cape Town 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Peter Nourse Red Cross War memmorial Childrens Hospital , Klipfontein Road, Rondebosch Cape Town 7700 South Africa University
Secondary Sponsor Andrew Argent Red Cross War memmorial Childrens Hospital , Klipfontein Road, Rondebosch Cape Town 7700 South Africa University
Secondary Sponsor Mignon McCulloch Red Cross War memmorial Childrens Hospital , Klipfontein Road, Rondebosch Cape Town 7700 South Africa University
Secondary Sponsor Brenda Morrow Red Cross War memmorial Childrens Hospital , Klipfontein Road, Rondebosch Cape Town 7700 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Tim Bunchman Children¿s Pavilion 1000 East Broad Street Fifth Floor, Rom 5-464 Richmond, Virginia 23298 United States of America
Stefano Picca Bambino Gesu Hospital, Piazza di Sant'Onofrio, 4 Rome 00165 Vatican City State (Holy See)
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Peter Nourse peter.nourse@uct.ac.za +27823789767 Red Cross War memorial Children's Hospital , Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Paediatric Nephrologist, Red Cross War Memorial children's Hospital, University of Cape Town
Role Name Email Phone Street address
Public Enquiries Peter Nourse peter.nourse@uct.ac.za +27823789767 Red Cross War Memorial Children's Hospital , Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Paediatric Nephrologist, Red Cross War Memorial children's Hospital, University of Cape Town
Role Name Email Phone Street address
Scientific Enquiries Peter Peter peter.nourse@uct.ac.za +27823789767 Red Cross War memmorial Childrens Hospital , Klipfontein Road, Rondebosch
City Postal code Country Position/Affiliation
Cape Town 7700 South Africa Paediatric Nephrologist, Red Cross War Memorial children's Hospital, University of Cape Town
REPORTING
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