FDA Toxicity Grading Scale for Preventive Vaccine Trials: Renal Reactions

Description

The Food and Drug Administration (FDA) has developed grading scales for reactions to vaccines during clinical trials. One of these scales deals with the kidneys and urine production.

Patient selection: renal reaction after the vaccination

Renal reactions may include:

(1) serum BUN

(2) serum creatinine

(3) urine protein

(4) urine glucose

(5) urine blood

Reduced urine output is not included as a measure.

Reaction	Grade
none	0
mild	1
moderate	2
severe	3
potentially life threatening	4

Renal Parameter	Finding	Grade
BUN	23 to 26 mg/dL	1
	27 to 31 mg/dL	2
	> 31 mg/dL	3
	requires dialysis	4
creatinine	1.5 to 1.7 mg/dL	1
	1.8 to 2.0 mg/dL	2
	2.1 to 2.5 mg/dL	3
	> 2.5 mg/dL	4
	requires dialysis	4
urine protein	trace	1
	1+	2
	2+	3
	hospitalized or requires dialysis	4
urine glucose	trace	1
	1+	2
	2+	3
	hospitalization for hyperglycemia	4
urine blood	1 to 10 RBC per hpf	1
	11 to 50 RBC per hpf	2
	> 50 per hpf	3
	gross blood	3
	hospitalized	4
	blood transfusion	4

To read more or access our algorithms and calculators, please log in or register.

FDA Toxicity Grading Scale for Preventive Vaccine Trials: Renal Reactions

Description

Specialty