Comparison effect of intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration in reducing of amphotericin B-induced nephrotoxicity
Phase 3
Recruiting
- Conditions
- ephrotoxicity.Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions
- Registration Number
- IRCT20161010030246N4
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
Age over 15 years
Receive amphotericin for at least 7 days
No history of kidney disease (including chronic kidney disease) and hemodialysis
Signing up the informed consent form
Exclusion Criteria
Heart failure class 3 and 4
Known liver failure
Known acute or chronic kidney disease
Alkalosis (pH greater than 7.5 or sodium bicarbonate plasma greater than 30 meq / lit)
Symptomatic hypocalcemia, hypokalemia or hypomagnesemia
Sensitivity and any adverse effect that occurred after the injection of bicarbonate in the patient.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Amphotericin b nephrotoxicity defined by either doubling of Scr from the baseline value or =50 % decrease in GFR. Timepoint: SCr and GFR are measured every other day during the intervention (Days 1, 3, 5 & 7). Method of measurement: Measurement of serum creatinine using an autoanalyzer device.;Electrolyte disorders including hypokalemia (serum level potassium below 3 mEq/L) and hypomagnesemia (serum magnesium level below 1.2 mEq/L). Timepoint: Serum potassium and magnesium levels are determined in the first and last days of the intervention (Days 1 & 7). Method of measurement: Measurement of serum electrolytes using an autoanalyzer device.
- Secondary Outcome Measures
Name Time Method