Amphotericin B associated nephrotoxicity and electrolyte disorders in patients with invasive fungal infections Amphotericin b Acute kidney injury Saline solution Plasmalyte A Hypokalemia Hypomagnesemia Acidosis
Conditions
Interventions
Prehydration with multiple electrolytes injection type 1, 1 L via intravenous route in 4 hours, 30 minutes before amphotericin B deoxycholate administation,Prehydration with normal saline solution 1 L
Experimental Drug,Active Comparator Drug
Prehydration with multiple electrolytes injection type 1,Prehydration with normal saline solution
Sponsors
Division of Nephrology, Department of Medicine, Khon Kaen Hospital
Royal College of Physicians of Thailand - monetary support,Thai Otsuka Pharmaceutical Co., Ltd. - study fluids/material support
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with invasive cryptococcosis and/or histoplasmosis/talaromycosis, treated with Amphotericin B deoxycholate combined with fluconazole or itraconazole for at least 14 days. 2. Age 18 years or older. 3. Hospitalized at Khon Kaen Hospital.
Exclusion criteria
Exclusion criteria: 1. Acute kidney injury with a pre-treatment serum creatinine level greater than 1.5 mg/dL. 2.Volume overload or heart failure. 3. Pre-treatment serum potassium less than 3 mEq/L, venous pH less than 7.2 accompanied by a venous base excess less than -5 mEq/L, or serum magnesium less than 1.2 mg/dL. 4. Hypotension requiring vasopressor support. 5. Terminally ill patients or those with untreatable malignant disease. 6. Active hepatitis, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels greater than or equal to 3 times the upper limit of normal (ULN). 7. A history of kidney transplantation or glomerulonephritis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| composite outcome of acute kidney injury/hypokalemia/metabolic acidosis and hypomagnesemia Day 0 to Day 14, with follow up at Day 28 Time to first occurrence of AKI by KDIGO creatinine criteria, hypokalemia, hypomagnesemia, or metabolic acidosis using protocol defined baseline adjusted thresholds from Day 0 to Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Acute kidney injury Day 0 to Day 14, with follow up at Day 28 Time to first occurrence of AKI by KDIGO creatinine criteria,Hypokalemia Day 0 to Day 14, with follow up at Day 28 Time to first occurrence of hypokalemia (serum potassium (K) below 3.5 in patients with baseline K 3.5 and above, or serum K less than 3 in patients with baseline K 3-3.49, in mEq/L),Hypomagnesemia Day 0 to Day 14, with follow up at Day 28 Time to first occurrence of hypomagnesemia (serum magnesium (Mg) below 1.7 in patients with baseline Mg 1.7 and above, or serum Mg below 1.2 in patients with baseline Mg 1.2-1.69, in mg/dL),Metabolic acidosis Day 0 to Day 14, with follow up at Day 28 Time to first occurrence of metabolic acidosis (standard base excess (SBE) below -2 in patients with SBE -2 or more, or SBE below -5 in patients with baseline SBE -2.01 to -5),Cumulative potassium supplementation Day 7 and Day 14 Total potassium supplementation from Day 0 to Day 7 and Day 0 to Day 14,Cumulative bicarbonate supplementation Day 7 and Day 14 Total bicarbonate supplementation from Day 0 to Day 7 and Day 0 to Day 14,Cumulative magnesium supplementation Day 7 and Day 14 Total magnesium supplementation from Day 0 to Day 7 and Day 0 to Day 14,Proportion of patients with acute kidney injury Day 7 and Day 14 Proportion with AKI by KDIGO creatinine criteria by Day 7 and Day 14,Severe hypokalemia Day 0 to Day 14, with follow up at Day 28 Time to first occurrence of severe hypokalemia (serum potassium below 2.5 mEq/L),Serial serum electrolyte and acid base parameters Day 0 and Days 2, 4, 6, 8, 10, 12, and 14, with follow up at Day 28 Serial measurements of serum sodium, potassium, chloride, bicarbonate, magnesium, pH, and base excess,Change in urinary indices from baseline Day 7, Day 14, and Day 28 Within group change in fractional excretion (FE) of sodium (FENa), FEUrea, urine pH, and urine potassium/creatinine index compared with baseline | — |
Countries
Thailand
Contacts
Public ContactPatkawin Khaigunha
Department of Medicine, Khon Kaen Hospital, Khon Kaen, Thailand
Outcome results
None listed