Skip to main content
. 2018 Oct 26;2018(10):CD007554. doi: 10.1002/14651858.CD007554.pub3

Takatori 2011.

Methods
  • Study design: parallel RCT

  • Study duration: May 2005 to April 2007

  • Follow‐up: 24 months

Participants
  • Country: Japan

  • Setting: multicentre (23 sites)

  • Adult incident PD patients (CAPD/APD) with ESKD because of diabetic kidney disease

  • Number: treatment group (21); control group (20)

  • Mean age ± SD (years): treatment group (55.9 ± 11.16); control group (56.5 ± 9.86)

  • Sex (M/F): treatment group (14/7); control group (13/7)

  • Exclusion criteria: age < 18 years or > 80 years; urine volume < 400 mL/d; urinary tract obstruction due to neoplasm; neurogenic bladder; pregnancy; previous renal replacement therapies including PD, HD and kidney transplantation

Interventions Treatment group
  • Treated with a maximum of 6 L of daily 1.5% or 2.5% Dianeal PD‐2 or PD‐4 in association with an overnight or daytime dwell of 2 or 1.5 L of 7.5% icodextrin‐containing solution


Control group
  • Treated with a maximum of 8 L of daily 1.5% or 2.5% Dianeal PD‐2 or PD‐4 (Baxter)

Outcomes Primary outcome
  • Rate at 2 years of PD technical survival


Secondary outcomes
  • Rate of decline in RRF

    • fluid status measured using body weight, BP, cardiothoracic ratio on CXR, UF volume

    • RRF measured with daily urine volume renal CrCl, weekly Kt/V measured at baseline, 3, 6, 12, 18 and 24 months from the initiation of PD

  • Status of lipid and glucose metabolism

    • haemoglobin A1c, glycoalbumin, LDL‐cholesterol, HDL‐cholesterol, triglycerides

Notes
  • Funding source: not reported

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 High risk Quote: "open‐label multicenter clinical trial". Given fluid balance is one of the major outcomes assessed, unblinded nature may have influenced introduction of co‐intervention
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk High dropout rate ‐ 18/41 (43.9%). However, the majority of dropouts (12) were due to reaching the primary endpoint (i.e. fluid overload), presence of attrition bias for other outcomes cannot be excluded
Selective reporting (reporting bias) Low risk All relevant clinical outcomes reported
Other bias Unclear risk Insufficient information to permit judgement