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

Eklund 1995.

Methods

  • Study design: parallel RCT

  • Study time frame/recruitment period: March 1990 to September 1991

  • Follow‐up period: to 30 September 1994
Participants

  • Country: Finland

  • Setting: Single centre

  • 40 consecutive patients selected for CAPD

  • Number: treatment group (20); control group (20)

  • Mean age, range (years): treatment group (48.5, 26 to 68); control group (43.7, 23 to 66)

  • Sex (M/F): treatment group (11/9); control group (11/9)

  • Diabetes: treatment group (6/20); control group (10/20)

  • Exclusion criteria: not reported
Interventions Treatment group

  • 2 cuff straight Tenckhoff catheter (straight intraperitoneal segment)


Control group

  • 2 cuff Swan neck catheter (straight intraperitoneal segment)


Other information

  • Catheters inserted surgically, spinal anaesthesia was used in all instances

  • Prior to insertion catheter was soaked in vancomycin 500 mg/10 mL saline solution and rest of antibiotic injected into rectus muscle
Outcomes

  • Peritonitis: diagnosed when 2 of the following criteria were fulfilled: abdominal pain; cloudy dialysate with leucocyte count of 100 cells/mm³ or more with 50% polymorphonuclear cells; positive microbiological culture from dialysate

  • Peritonitis rate

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

  • Exit‐site infection rate

  • Catheter removal or replacement

  • Death
Notes

  • Dropout definitions: catheter removal due to successful transplantation, elective transfer to HD or death from concurrent disease with functioning catheter were censored at the time of the event

  • 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) Low risk Sequentially numbered sealed envelopes containing catheter configurations in random order
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not blinded
Incomplete outcome data (attrition bias) 
 All outcomes High risk High dropout (14/40, transferred to HD or death)
Selective reporting (reporting bias) Low risk All outcomes were reported
Other bias Unclear risk Insufficient information to permit judgement