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. 2019 May 31;2019(5):CD004680. doi: 10.1002/14651858.CD004680.pub3

Xie 2011a.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: October 2006 and February 2008

  • Follow‐up period: Coiled (median: 31 months), straight (44 months); all patients are followed up until death, kidney, transplant, completion of CAPD or end of the study in December 2010, whichever came first
Participants

  • Country: China

  • Setting: single centre

  • Aged 18 to 80 years with presence of ESKD and initiated PD in the hospital; expected survival > 6 months

  • Number: treatment group (40); control group (40)

  • Mean age ± SD (years): treatment group (63 ± 13); control group (60 ± 13)

  • Sex (M/F): treatment group (24/16); control group (25/15)

  • Diabetes: treatment group (8/40); control group (8/40)

  • Exclusion criteria: unstable or poorly controlled CAD; severe congestive heart failure; severe chronic respiratory disease; malignant disease; clinically significant liver disease; AKI; psychiatric disease; previous abdominal surgery; pregnant or lactating women
Interventions Treatment group

  • Double‐cuffed coiled Swan neck catheter


Control group

  • Double‐cuff straight‐end swan neck catheter (Quinton; straight group)
Outcomes

  • Catheter tip migration with dysfunction

  • All‐cause catheter failure: defined as necessity to remove or reposition the catheter by surgical methods

  • Catheter‐related infections: including peritonitis, exit‐site infection, and tunnel infection

  • Technique survival: defined as time to permanent transition to HD therapy

  • Overall patient survival
Notes

  • Funding source: "This work was supported by the National Basic Research Program of China 973 Program No. 2012CB517600 (No.2012CB517604), the National Natural Science Foundation of China (No. 81000295), Leading Academic Discipline Project of Shanghai Health Bureau (05III 001 and 2003ZD002) and Shanghai Leading Academic Discipline Project (T0201). Dr Xie is supported by the Schrier Family Fellowship from the International Society of Nephrology"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer generated random numbers
Allocation concealment (selection bias) Low risk "Randomization was performed using sequentially numbered opaque sealed envelopes"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Low dropout (1/80)
Selective reporting (reporting bias) High risk Not all the outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement