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. 2014 Aug 13;2014(8):CD003078. doi: 10.1002/14651858.CD003078.pub2

Li 1999.

Methods RCT
Method of random allocation: not described; states randomisation was single‐blinded but remains unclear who was blinded.
Masking:
 states single‐ blinded study but unclear who was blinded.
Description of withdrawals and dropouts: numbers and reasons clearly stated ‐ treatment group ‐ 9 (opted not to use Y‐set ‐ 7; incomplete data ‐ 2).
Analysis on intention to treat basis: no
Duration of follow‐up:
 all patients followed for at least 12 months.
 Treatment group ‐ 937 patient‐months; control group ‐ 734 patient‐months.
Participants 120 new ESRD patients admitted to CAPD programme.
60 in treatment group and 60 in control group (data on only 51 reported, see above).
Male:female ratio: treatment group ‐ 28:32; control group ‐ 26:25.
Age (mean,SD): treatment group ‐ 53.4(13.4) years; control group 49.3(14.2) years.
 Primary renal disease: treatment group ‐ glomerulonephritis (14); diabetes (11); adult polycystic kidney disease (2); hypertension (3); renal stone disease (5); others/unknown (25); control group ‐ glomerulonephritis (13); diabetes (11); adult polycystic kidney disease (4); hypertension (3); renal stone disease (0); others/unknown (20).
Co‐morbidity: treatment group ‐ diabetes (15); HBsAg carriers (10); control group ‐ diabetes (14); HBsAg carriers (5).
Interventions Double bag disconnect system (Ultrabag, Baxter) "pre‐assembled and sterilised as single unit". (treatment) vs Y‐set disconnect system (Ultraset, Baxter)(control).
3 exchanges per day.
Outcomes Peritonitis
 Exit site infections
 Patient acceptance
 Hospitalisation
 Catheter removal
 Mortality
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Allocation concealment (selection bias) Unclear risk B ‐ Unclear