Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NCT31143456
Study information
Scientific title
A prospective, randomised, controlled trial to compare the clinical outcomes of coiled-end versus straight-end Swan-Neck peritoneal dialysis (PD) catheters in Chinese Han population
Acronym
Study hypothesis
A reliable permanent access is the key factor in the successful delivery of peritoneal dialysis (PD).
The main objective of catheter design is to reduce the risk of mechanical and infectious complications. Variations in the design of peritoneal catheters include different numbers of cuffs (single vs double), different shapes of subcutaneous paths (permanently-bent Swan neck catheter vs straight Tenckhoff catheter) and different shapes of intra-abdominal segments (straight vs coiled).
A recent systematic review demonstrated that the benefits of various design types have been studied poorly.Most published studies are limited by a small sample size and various design problems, such as lack of stratification by surgeon and presence of several interventions (eg. single vs double cuff, Swan-Neck vs Tenckhoff, Moncrief-Popovich vs conventional insertion technique, median vs lateral insertion site, etc). As a result, the International Society for Peritoneal Dialysis (ISPD) is unable to provide definitive guidelines for catheter choice. Moreover, most studies have been performed in Caucasians, and there is general lack of data relevant to Asian populations. It is generally believed that this design allows for less dialysate inflow pain and less propensity for catheter migration. However, two recent studies have suggested that coiled catheters may be associated with a greater rate of drainage dysfunction due to catheter tip migration and may require replacement more frequently compared to straight catheters. These observations prompted our randomised controlled trial (RCT) with the primary hypothesis that coiled-end catheters may be more prone to catheter tip migration and resultant catheter dysfunction.
Ethics approval
Hospital Ethics Committee for Human Research, approved on 14th May 2006, ref no: RJYY200605005
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
End stage renal disease requiring renal replacement therapy
Intervention
The patients of two groups were randomised to be inserted with a coiled or a straight Swan-neck peritoneal catheter. After the catheter insertion, the twin bag system, lactate dialysate (Dianeal, Baxter, China) with glucose concentration 1.5% or 2.5%, with a dialytic dose of 6-8 L per day was used.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Catheter tip migration defined as catheter tip located above the pelvic brim on the abdominal X-ray with associated catheter dysfunction
Secondary outcome measures
1. All-cause catheter failure (defined by a necessity to remove or reposition the catheter by surgical methods)
2. Catheter related infections (including peritonitis, exit-site infection and tunnel infection)
3. Technique survival (defined as time to permanent transition to haemodialysis) and overall patient survival
Overall trial start date
01/10/2006
Overall trial end date
28/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18 and 80
2. Presence of end stage renal disease (ESRD)
3. Initiation of Continuous Ambulatory Peritoneal Dialysis (CAPD) therapy in our hospital
4. Expected survival greater than 6 months
5. Provision of informed consent to participate in the study
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 patients with coiled end catheter and 40 patients with straight end catheter
Participant exclusion criteria
1. Unstable or poorly controlled coronary artery disease
2. Severe congestive heart failure (New York Heart Association Grade III or IV)
3. Severe chronic respiratory disease, malignant disease, clinically significant hepatic disease, acute renal failure and psychiatric disease
4. Women who were pregnant or lactating
Recruitment start date
01/10/2006
Recruitment end date
28/02/2008
Locations
Countries of recruitment
China
Trial participating centre
197 Ruijin Er Road
Shanghai
20025
China
Funders
Funder type
Government
Funder name
Leading Academic Discipline Project of Shanghai Health Bureau (China) (05III 001 and 2003ZD002)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Shanghai Leading Academic Discipline Project (China) (T0201)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The National Natural Science Foundation (China) (81000295)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21872978
Publication citations
-
Results
Xie J, Kiryluk K, Ren H, Zhu P, Huang X, Shen P, Xu T, Chen X, Chen N, Coiled versus straight peritoneal dialysis catheters: a randomized controlled trial and meta-analysis., Am. J. Kidney Dis., 2011, 58, 6, 946-955, doi: 10.1053/j.ajkd.2011.06.026.