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. 2021 Feb 15;2021(2):CD013109. doi: 10.1002/14651858.CD013109.pub2

Yongsiri 2015.

Study characteristics
Methods

  • Study design: cross‐over RCT (2‐week washout period)

  • Study duration: March 2013 to May 2013

  • Follow‐up duration: 10 weeks (total study time)
Participants

  • Setting: single centre

  • Country: Thailand

  • Relevant health status: CKD‐5D on PD; history of hypokalaemia (serum potassium < 3.5 mEq/L) or required potassium supplements to maintain a normal serum potassium at any time in the past

  • Number: 24

  • Mean age ± SD (years): 52.4 ± 12.4

  • Sex (M/F); 8/12

  • Exclusion criteria: history of hyperkalaemia (serum K+ > 5.5 mEq/L) at any time in the past and recent peritonitis within one month
Interventions Treatment group

  • Spironolactone: 25 mg/day for 12 weeks


Control group

  • Placebo for 12 weeks
Outcomes

  • Serum potassium

  • Residual kidney function: urine volume

  • Fatigue
Identification

  • Authors name: Somchai Yongsiri

  • Institution: Faculty of Medicine, Burapha University

  • Email: syongsiri@yahoo.com

  • Address: Chonburi 20131, Thailand
Notes

  • Funding source: This study was supported by the Office of the Higher Education Commission of Thailand and Faculty of medicine, Burapha University, Thailand.

  • Complete follow‐up: (20/24, 83.3%)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Block randomisation was done by a computerized program."
Allocation concealment (selection bias) Low risk Quote: "Block randomisation was done by a computerized program."
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "randomised, double‐blind, placebo‐controlled cross‐over study"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "randomised, double‐blind, placebo‐controlled cross‐over study"
Incomplete outcome data (attrition bias)
All outcomes High risk More than 10% of participants were not followed up
Selective reporting (reporting bias) Low risk Quote: "The study protocol was approved by the institutional review board of Burapha University and registered at http://www.clinicaltrials.in.th, identification number TCTR20130314001."
Other bias Low risk Quote: "This study was supported by the Office of the Higher Education Commission of Thailand and Faculty of Medicine"