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

Gross 2005.

Study characteristics
Methods

  • Study design: cross‐over RCT (3‐week washout period)

  • Study duration: not reported

  • Follow‐up period: 7 weeks (total study time)
Participants

  • Setting: single centre

  • Country: USA

  • Relevant health status: CKD‐5D on HD; nil or minimal urine output (< 500 mL/24 hours)

  • Number: 8

  • Mean age ± SD: 53.0 ± 10.0 years

  • Sex (M/F): 3/5

  • Exclusion criteria: women of childbearing age had a negative pregnancy test result before entering into the study; known allergy to spironolactone; any acute illness; hypotension, defined as a predialysis SBP < 100 mm Hg; severe hypertension (predialysis SBP > 180 mm Hg and/or DBP > 100 mm Hg); decompensated heart failure; inability to give informed consent; noncompliance
Interventions Treatment group

  • Spironolactone: 50 mg twice/day for 2 weeks


Control group

  • Placebo for 2 weeks
Outcomes

  • Serum potassium

  • Residual kidney function: 24 hour urine volume
Identification

  • Authors name: Henrikas Irmantas Juknis, MD

  • Institution: Department of Internal Medicine, Renal Division, Washington University School of Medicine, St Louis, MO

  • Email: ijuknevi@im.wustl.edu

  • Address: 4205 Forest Park Ave, St Louis, MO 63108.
Notes

  • Funding source: not reported

  • Complete follow‐up: (8/8, 100%)
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 sequence generation was done
Blinding of participants and personnel (performance bias)
All outcomes Low risk Quote: "double‐blind", "placebo‐controlled"
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "double‐blind", "placebo‐controlled"
Incomplete outcome data (attrition bias)
All outcomes Low risk Missing outcome data balanced across intervention groups
Selective reporting (reporting bias) Unclear risk The study protocol is not available
Other bias Unclear risk Funding: not reported