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. 2018 Oct 26;2018(10):CD007554. doi: 10.1002/14651858.CD007554.pub3

BALNET 2008.

Methods

  • Study design: open‐label, parallel RCT

  • Study recruitment period: June 2004 to May 2006

  • Follow‐up period: 12 months (24‐month follow‐up result in abstract form available)
Participants

  • Country: South Korea

  • Setting: multicentre (4 sites)

  • Incident adult patients > 18 years commencing on CAPD

  • Number: treatment group (48); control group (43)

  • Mean age ± SD (years): treatment group (55.3 ± 13.2); control group (52.8 ± 13.6)

  • Sex (M/F): treatment group (31/17); control group (24/19)

  • Exclusion criteria: mechanical problems with PD catheter; expected kidney transplantation within 12 months; life expectancy < 6 months; plans to transfer to another hospital; dialysis required due to acute renal failure; patient refusal
Interventions Treatment group

  • Low‐GDP solution (Balance)


Control group

  • Conventional PD solution


After 4‐week run‐in phase on conventional fluid, each group started CAPD with the designated PD solution
Outcomes Primary end point

  • GFR defined by the mean of renal urea and CrCl


Secondary end points

  • Urine volume

  • Survival: patient survival, technique survival and peritonitis‐free survival

  • Clinical laboratory data: peritoneal solute transport rate represented by dialysate‐to‐plasma ratio for creatinine at 4h (D/P Cr) and blood chemistry
Notes

  • Partly supported by Fresenius Korea
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 Low risk Quote: "open‐labelled, randomised, prospective study" However, unlikely to have influenced the objective outcomes measured
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk Dropout rate, 22/91 (24.1%), 5/48 patients in low GDP group switched to HD ‐ no reason specified that may have been relevant to the therapy they had received
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias Unclear risk Insufficient information to permit judgement