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

DIUREST 2010.

Methods
  • Study design: open, parallel RCT

  • Study duration: 1999 to 2005

  • Follow‐up period: 18 months

Participants
  • Country: Germany, France, Austria

  • Setting: multicentre (23 sites)

  • Adult patients on CAPD or APD aged 18 to 80 years; ESKD, GFR ≥ 3 mL/min (arithmetic mean of renal urea and CrCl) or ≥ 6 mL/min (CrCl) as measured by 24‐hour urine collection

  • Number: treatment group (44); control group (36)

  • Mean age ± SD (years): treatment group (52 ± 12); control group (53.8 ± 14.6)

  • Sex (M/F): treatment group (36/18); control group (14/12)

  • Exclusion criteria: pregnant or breastfeeding; severe peritonitis episodes; cancer; positive for hepatitis B, hepatitis C and HIV

Interventions Treatment group
  • Received either Gambosol trio, a multi‐compartment bag with minimal amounts of GDPs (3, 4‐DGE < 1 µM)


Control group
  • Standard PD fluids from different manufacturers in single compartment bags, all containing 3,4‐DGE (13‐20 µM)

Outcomes
  • RRF (arithmetic mean of renal creatinine and urea clearance)

  • Assessment of fluid balance (body weight, 24‐hour urine volume)

  • Serum parameters (CRP, total protein, albumin, electrolytes and phosphate)

  • CA125 in PD effluent

  • Assessment of peritoneal membrane transport characteristics

  • Medications (e.g. BP medications, diuretics and phosphate binders)

Notes
  • Sponsored by Gambro

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote from Methods section of paper: "Randomization was performed by means of a centrally managed list based on a table of random numbers in blocks of four and stratified for the presence of diabetes"
Allocation concealment (selection bias) Low risk Quote from Methods section of paper: "Randomization was performed by means of a centrally managed list based on a table of random numbers in blocks of four and stratified for the presence of diabetes"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote from Methods section of paper: "... open, parallel study". As fluid balance is one of the main outcomes assessed, risks influencing co‐intervention
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 drop‐out rate (41/80 (51.3%)), imbalance between the number of dropouts from each arm. Per protocol analysis
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias Unclear risk Insufficient information to permit judgement