Skip to main content
. 2021 Feb 15;2021(2):CD013109. doi: 10.1002/14651858.CD013109.pub2

Vukusich 2010.

Study characteristics
Methods
  • Study design: parallel RCT

  • Study duration: not reported

  • Follow‐up duration: 2 years

Participants
  • Setting: single centre

  • Country: Chile

  • Relevant health status: CKD‐5D on HD

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

  • Mean age ± SD (years): treatment group (60.1 ± 5.2); control group (55.6 ± 3.6)

  • Sex (M/F): treatment group (14/9); control group (20/10)

  • Exclusion criteria: pregnancy or potassium level > 5.5 mEq/L

Interventions Treatment group
  • Spironolactone 50 mg/HD for 104 weeks


Control group
  • Placebo for 104 weeks

Outcomes
  • Death (any cause)

  • Serum potassium

Identification
  • Authors name: Antonio Vukusich

  • Institution: Faculty of Medicine, Universidad Los Andes, Santiago

  • Email: emarusic@uandes.cl

  • Address: S. Carlos Apoquindo2200, Santiago, Chile

Notes
  • Funding source: This research was supported by grants FONDECYT 1040338 and Fondo Ayuda Investigaction Universidad Los Andes MED 002/06.

  • Complete follow‐up: treatment group (30/33, 90.9%); control group (23/33, 69.7%)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Only states the study was randomised, does not ensure how sequence generation was done
Allocation concealment (selection bias) Unclear risk Only states the study was randomised, does not ensure how allocation concealment was done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "placebo‐controlled randomised clinical trial"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "placebo‐controlled randomised clinical trial"
Incomplete outcome data (attrition bias)
All outcomes High risk Imbalance in numbers for missing data across intervention groups
Selective reporting (reporting bias) Low risk All prespecified outcomes have been reported in study protocol in materials and methods section
Other bias Low risk This research was supported by grants FONDECYT 1040338 and Fondo Ayuda Investigacion Universidad Los Andes MED 002/06