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

Carrasco 2001.

Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up period: 3 months

Participants
  • Country: Spain

  • Setting: multicentre (4 sites)

  • Prevalent adult CAPD patients

  • Number: treatment group (20); control group (11)

  • Age, range (years): treatment group (58.8, 23 to 76); control group (56.7, 34 to 79)

  • Sex (M/F): treatment group (9/11); control group (5/6)

  • Exclusion criteria: antibiotics during the previous 30 days; serious illnesses (e.g. requiring hospitalisation during the previous 30 days); HIV positive; pregnancy or lactating; bicarbonate supplementation into PD fluids or orally

Interventions Treatment group
  • 25 mmol/L bicarbonate/15 mmol/L lactate PD solution


Control group
  • Standard 35 mmol/L lactate PD solution

Outcomes
  • Venous plasma bicarbonate concentrations

  • Vital signs

Notes
  • This was a study primarily examining the ability of the new bicarbonate/lactate PD solutions on improving acidosis in PD patients

  • Author contacted, awaiting response

  • Funding received from Baxter Healthcare Ltd

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Block randomisation (3 patients/block)
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Open label, however, unlikely to have affected measured outcomes
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No drop‐outs
Selective reporting (reporting bias) High risk Limited reporting of clinical outcomes
Other bias Unclear risk Insufficient information to permit judgement