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

MIDAS 1994.

Methods
  • Study design: parallel RCT

  • Study duration: March 1991 to February 1992

  • Follow‐up period: 6 months

Participants
  • Country: UK

  • Setting: multicentre (11 sites)

  • Prevalent adult patients on CAPD ≥ 18 years or older and established on CAPD for at least 3 months using standard 3 to 4 exchanges, with no more than one hypertonic (3.86% glucose) bag/24 hours; free of peritonitis and mechanical drainage complications for at least one month prior to the study

  • Number: treatment group (103); control group (106)

  • Mean age ± SD (years): treatment group (55 ± 15); control group (55 ± 14)

  • Sex (M/F): treatment group (67/36); control group (71/35)

  • Exclusion criteria: not reported

Interventions Treatment group
  • 7.5% icodextrin as overnight dwell


Control group
  • Standard glucose‐containing PD fluid as overnight dwell

Outcomes
  • Death (all causes)

  • Peritonitis rate

  • Peritoneal UF

Notes
  • Study supported by ML Laboratories plc and conducted by Innovata Biomed Limited

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "telephone from a single office (Innovata Biomed) at the first visit"
Allocation concealment (selection bias) Low risk Quote: "telephone from a single office (Innovata Biomed) at the first visit"
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Although mod‐high dropout rate (71/209 (34%)), all missing participants are accounted for and reasonably balanced in terms of cause
Selective reporting (reporting bias) High risk RRF not reported
Other bias Unclear risk Insufficient information to permit judgement