Use of Spironolactone for the Prevention of Electrolyte Abnormalities in Patients Treated With Amphotericin B
Phase 4
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Both
Patients With Indications for AmB Treatment
Both
Patients With Indications for AmB Treatment
Trial Information
Use of Spironolactone for the Prevention of Electrolyte Abnormalities in Patients Treated With Amphotericin B
Inclusion Criteria:
- Patients with indications for AmB treatment
Exclusion Criteria:
- Patients with acute kidney injury
- Hyperkalemia ≥5.2
- Hypersensibility to spironolactone
- HIV infection
- Pregnant women
- Solid organ transplant
- Hemodinamic instability
- CKDEPI ≤30ml/min/1.73m3
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Incidence of hypokalemia ≤3.5mEq/L
Outcome Description:
Researchers will collect daily plasma potassium
Outcome Time Frame:
Up to the 5th day
Safety Issue:
No
Authority:
Mexico: Secretaria de Salud
Study ID:
AMPHYRO-628
NCT ID:
NCT01843309
Start Date:
May 2013
Completion Date:
Related Keywords:
- Patients With Indications for AmB Treatment
- Congenital Abnormalities
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