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

A clinical trial with a control group with parallel groups, single-blind, randomized and sampling groups was 40 patients. In this study, there was no factor in the classification of patients in the two groups.

A randomized, single-blind clinical trial will be carried out at the Shiraz University of Medical Sciences , Namazi Hospital. BUN and Scr values will be determined for each patient every other day during the study period (days 1, 3, 5 and 7). GFR will be also calculated every other day by MDRD formula. Serum potassium and magnesium levels will be determined at days 1 & 7 of the intervention.

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: Cardiac failure class 3 and 4, Known liver failure, Known kidney failure, 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.

group 1:Includes 20 patients with 1000 ml normal saline 0.9% equivalent to 159 mEq in two divided doses (500 ml) before and after infusion of amphotericin that is given to patients. group2: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 to the normal saline mEq 159, sodium bicarbonate that is given to patients.

Nephrotoxicity of amphotericin B

Clinical trials are simple randomized, one-blind, and placebo-free that the patient did not know. The possibility of double-blind due to the lack of a clean room and the required facilities as well as the different appearance of sodium bicarbonate and sodium chloride Did not have. unit of randomization is individual a randomization method using a random number table.

This study was conducted in a single blind setting that That the participants are blind in this study. It is impossible to conduct this clinical trial as double-blinded due to the lack of a clean room and the required facilities as well as the appearance of the sodium bicarbonate and sodium chloride looks different.

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