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

Ouyang 2015.

Methods
  • Study design: parallel RT

  • Study time frame/recruitment period: November 2007 to August 2008

  • Follow‐up period: 24 months

Participants
  • Country: China

  • Setting: single centre

  • All ESKD patients ≥ 18 years who underwent a first PD catheter placement

  • Number: treatment group (90); control group (99)

  • Mean age ± SD (years): treatment group (50.3 ± 14.1); control group (49.1 ± 15.6)

  • Sex (M/F): treatment group (49/41); control group (54/45)

  • Diabetes: not reported

  • Exclusion criteria: AKI; referral for kidney transplantation evaluation within 3 months; acute heart failure; acute MI within 3 months; acute respiratory distress syndrome at the time of enrolment; malignant disease; psychiatric disease

Interventions Treatment group
  • Coiled tip Tenckhoff Catheter


Control group
  • Straight tip Tenckhoff catheter


Other information
  • All placements were performed by one of two designated experienced nephrologists

  • A prophylactic 2nd or 3rd‐generation cephalosporin was administered intravenously 1 hour before the catheter placement procedure

  • Patients underwent PD therapy immediately after the successful catheter placement and transited to continuous ambulatory PD 7 days later

Outcomes
  • 1‐year and 2‐year catheter survival

  • Death, transfer to HD, kidney transplantation, refusal of PD therapy, or recovery of kidney function

  • Catheter dysfunction

  • Peritonitis diagnosed when two of the following conditions were present: abdominal pain; cloudy effluent with an effluent white cell count of more than 100/μL (≥ 50% polymorphonuclear neutrophils); or a positive effluent culture

  • Exit‐site infection: defined as erythema with or without skin induration and purulent discharge from the exit site

Notes
  • Additional data requested from authors

  • Funding source: not reported

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Insufficient information to permit judgement
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
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 High risk 22% dropout (43/189)
Selective reporting (reporting bias) Low risk All the outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement