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Comparison effect of intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration in reducing of amphotericin B-induced nephrotoxicity

Comparison effect of intravenous sodium bicarbonate and sodium chloride combination versus intravenous sodium chloride hydration in reducing of amphotericin B-induced nephrotoxicity

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20161010030246N4
Enrollment
40
Registered
2019-09-08
Start date
2018-10-23
Completion date
Unknown
Last updated
2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephrotoxicity. Drug- and heavy-metal-induced tubulo-interstitial and tubular conditions

Interventions

Intervention 1: Intervention group: Includes 20 patients who received 500 ml of normal saline before injection of amphotericin and 1.5 vial sodium bicarbonate vial in 500 cc dextrose water, equivalent

Sponsors

Shiraz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to No maximum

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactIman Karimzadeh

Shiraz University of Medical Sciences

karimzadehiman@yahoo.com+98 71 3242 5374

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026