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

Coles 1997.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up period: 2 months, with optional 4 month extension period

Participants
  • Countries: UK, Italy

  • Setting: multicentre (5)

  • Prevalent adult patients on CAPD for at least 3 months; receiving Dianeal PD4 for at least 1 month; RRF of ≤ 5 mL/min; weekly (renal + peritoneal) CrCl of ≥ 50 L/1.73 m2 RRF ≥ 5 mL/min; using 4 or 5, 2 litre bags/24 hours with no dry period

  • Number: treatment group 1 (20); treatment group 2 (20); control group (19)

  • Age, range (years): treatment group 1 (54.5, 21.6 to 73.7); treatment group 2 (54.8, 27.8 to 79.1); control group (58.4, 25.5 to 74.7)

  • Sex (M/F): treatment group 1 (17/3); treatment group 2 (13/7); control group (10/9)

  • Exclusion criteria: low peritoneal transport (4‐hour dialysate:plasma creatinine < 0.5); known to be HIV positive; peritonitis within the previous 30 days; suffered from liver disease or diabetes mellitus; added medication routinely to the dialysis bag

Interventions Treatment group 1
  • Bicarbonate‐buffered (38 mmol/L bicarbonate) dialysis fluid


Treatment group 2
  • Bicarbonate/lactate‐buffered (25 mmol/L bicarbonate, 15 mmol/L lactate) dialysis fluid


Control group
  • Conventional lactate‐buffered (40 mmol/L lactate) dialysis fluid

Outcomes
  • Peritoneal UF at 2 months

  • Peritonitis

  • Abdominal pain

  • Other adverse events

Notes
  • Funding received from Baxter Healthcare Corporation, Brussels, Belgium

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation in groups of 3, done separately for each centre; actual method of randomisation not reported
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open label. Measured outcome (e.g. abdominal pain) may have been influenced by lack of blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk Drop‐out 13/59 (22%). Unequal between three groups with peritonitis being the major cause which may have been due to the treatment received
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias Unclear risk Insufficient information to permit judgement