Study to compare the clinical outcomes of coiled-end versus straight-end Swan-Neck peritoneal dialysis (PD) catheters

ISRCTN ISRCTN05846916
DOI https://doi.org/10.1186/ISRCTN05846916
Secondary identifying numbers NCT31143456
Submission date
16/02/2011
Registration date
28/02/2011
Last edited
10/01/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Nan Chen
Scientific

197 Ruijin Er Road
Shanghai
20025
China

Study information

Study designProspective randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA 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
Study objectivesA 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(s)Hospital Ethics Committee for Human Research, approved on 14th May 2006, ref no: RJYY200605005
Health condition(s) or problem(s) studiedEnd stage renal disease requiring renal replacement therapy
InterventionThe 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 typeOther
Primary outcome measureCatheter tip migration defined as catheter tip located above the pelvic brim on the abdominal X-ray with associated catheter dysfunction
Secondary outcome measures1. 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 study start date01/10/2006
Completion date28/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants40 patients with coiled end catheter and 40 patients with straight end catheter
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/10/2006
Date of final enrolment28/02/2008

Locations

Countries of recruitment

  • China

Study participating centre

197 Ruijin Er Road
Shanghai
20025
China

Sponsor information

Shanghai Ruijin Hospital, Shanghai Jiaotong University, School of Medicine (China)
University/education

197 Ruijin Er Road
c/o Prof Nan Chen
Shanghai
20025
China

ROR logo https://ror.org/01hv94n30

Funders

Funder type

Government

Leading Academic Discipline Project of Shanghai Health Bureau (China) (05III 001 and 2003ZD002)

No information available

Shanghai Leading Academic Discipline Project (China) (T0201)

No information available

The National Natural Science Foundation (China) (81000295)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2011 Yes No
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