| Methods |
Study design: parallel RCT Study time frame/recruitment period: August 1987 to February 1989 Follow‐up period: 5 years (31 October 1992) |
| Participants |
Country: Finland Setting: single centre Consecutive patients selected for CAPD Number: treatment group (20); control group (20) Mean age, range (years): treatment group (42.8, 19.5 to 61.0); control group (49.0, 28.5 to 65.3) Sex (M/F): treatment group (9/11); control group (12/8) Diabetes: treatment group (3/20); control group (10/20) Exclusion criteria: not reported |
| Interventions |
Treatment group
Control group
Other information
Catheters inserted surgically by the same surgeon, spinal anaesthesia was the preferred choice Prior to insertion catheter was soaked in vancomycin 500 mg/10 mL saline solution and rest of antibiotic injected into rectus muscle After implantation peritoneal cavity flushed with 1 to 3, 1L exchanges until effluent clear. Catheter was then filled with 2 mL saline and 1 mL heparin (5000 U) CAPD training and treatment was started 10‐14 days after implantation
|
| Outcomes |
Peritonitis: diagnosed when 2 of the following criteria were fulfilled: abdominal pain; cloudy dialysate with leucocytes > 50/mm³; 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 were regarded as lost to follow‐up Funding source: "This study was supported by the Sigrid Juselius Foundation" |
| 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 |
Low risk |
No dropouts |
| Selective reporting (reporting bias) |
Low risk |
All outcomes were reported |
| Other bias |
High risk |
Definition of peritonitis was different from the ISPD guidelines |
