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

Schmitt 2002.

Methods
  • Study design: open cross‐over RCT

  • Study duration: not reported

  • Follow‐up period: 12 weeks

Participants
  • Countries: Austria, France, Germany

  • Setting: multicentre (6 specialised paediatric dialysis units)

  • Prevalent paediatric patients < 18 years on APD with an average peritoneal fill volume close to 1000‐1100 mL/m2 BSA

  • Number: 28

  • Median age (range): 6.0 years (range 0.6 to 15.7)

  • Sex (M/F): 19/9

  • Exclusion criteria: severe chronic pulmonary, cardiac, hepatic or malignant disease; history of peritonitis in the previous 3 weeks; clinical evidence of major peritoneal adhesions

Interventions Treatment group
  • Neutral pH PD fluid (34 mM bicarbonate, BicaVera 170/180/190; Fresenius Medical Care)


Control group
  • Conventional PD fluid (35 mL lactate, pH 5.5, CAPD 17/18/19; Fresenius Medical Care)


Patients performed their usual APD regimen with either the control or treatment fluid for 12 weeks. After a 4 week washout period they completed 12 weeks of APD using the alternative fluid
Outcomes
  • Peritonitis rate, relapsing peritonitis rate

  • Other adverse events (acute fluid overload, aggravated hypertension, severe hyperparathyroidism)

  • Residual GFR

  • 24‐hour UF

  • Peritoneal transport (4‐hour dialysate:plasma creatinine)

Notes
  • Funding received from Fresenius Medical Care (Bad Homburg, Germany)

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 Open‐label, however, unlikely to have influenced the objective outcome measures reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes High risk High dropout rate (12/28, 43%), unclear during which phase of treatment the dropouts occurred. Per protocol analysis
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias Unclear risk Insufficient information to permit judgement