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

STARCH 2015.

Methods

  • Study design: parallel RCT

  • Study duration: October 2009 to February 2013

  • Follow‐up period: 3 months
Participants

  • Country: Brazil

  • Setting: multicentre (7 sites)

  • Prevalent APD patients

  • Number: treatment group (33); control group (27)

  • Mean age ± SD (years): treatment group (51.6 ± 16.6); control group (52.2 ± 16.4)

  • Sex (M/F): treatment group (14/19); control group (12/15)

  • Exclusion criteria: not willing to participate in the study; Charlson Index of > 7 or a life expectancy of <1 year at baseline; positive HIV serology; peritonitis episode preceding the randomisation by 1month; any hospitalisation due to cardiovascular, metabolic or infectious disease in the month preceding randomisation; any known active cancer, pregnancy; known allergy to starch; a total Kt/V of <1.7 following the initial change in the prescription
Interventions Treatment group

  • Icodextrin solution 2L per day


Control group

  • Conventional dextrose solution
Outcomes

  • Glucose control

  • Urine volume

  • UF

  • Peritonitis rate

  • Hospitalisation rate

  • Technique failure rate
Notes

  • "This was an investigator‐driven clinical trial funded by Baxter Healthcare after approval of the Clinical Evidence Council. The sponsor did not participate in interpretation of results and in preparation of manuscript"
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Centralized randomisation schedule in coordinating centre with Random allocation software
Allocation concealment (selection bias) Low risk Centralized randomisation using random allocation software
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Open‐label, unlikely to affect outcome
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 11% dropout rate
Selective reporting (reporting bias) High risk limited outcomes of study reported
Other bias Unclear risk Insufficient information to permit judgement