Condition category
Urological and Genital Diseases
Date applied
16/02/2011
Date assigned
28/02/2011
Last edited
10/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Nan Chen

ORCID ID

Contact details

197 Ruijin Er Road
Shanghai
20025
China

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 measures

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

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

Sponsor information

Organisation

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

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21872978

Publication citations

  1. 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.

Additional files

Editorial Notes