Balanced electrolyte solution vs isotonic saline in the resuscitation of children with diabetic ketoacidosis: A randomized controlled trial

Table 1 Baseline characteristics of study participants, n (%)/median (25^th-75^th percentiles)/mean ± SD

Characteristics	BES (n = 30)	NS (n = 30)	P value
Age (years)	10.77 ± 1.36	10.63 ± 1.5	0.72
Female	23 (76.7)	21 (70)	0.56
Anthropometric parameters
Weight (kg)	19.2 ± 6.5	19.5 ± 6.4	0.84
Height (cm)	131.2 ± 24.1	130.9 ± 24.3	0.77
BMI (kg/m2)	19.6 ± 3.4	19.4 ± 3.5	0.92
Socio-economic status (poor)	6 (20)	5 (16.7)	0.63
Family history of diabetes	3 (10)	2 (6.7)	0.44
Known case of diabetes	10 (33.3)	11 (36.7)	0.59
Age (year) at onset of diabetes	5 ± 2	5 ± 2	0.99
Previous history of DKA	16 (53.3)	17 (56.7)	0.73
Precipitating event present	15 (50)	17 (56.7)	0.42
Infection present	9 (30)	7 (23.3)	0.39
Poor compliance	17 (56.7)	18 (60)	0.65
Severity of DKA at presentation
Mild	2 (3.3)	2 (6.7)
Moderate	7 (6.9)	8 (3.3)	0.39
Severe	21 (70)	20 (66.7)
Shock at presentation	2 (6.7)	1 (3.3)	0.17
GCS at admission	13 ± 2	13 ± 2	0.97
Blood glucose (mg/dL)	452 (364-548)	448 (354-542)	0.48
Hb1Ac (%)	9.8 (8.8-12)	9.6 (8.6-11.5)	0.76
Laboratory parameters
Blood pH	7.01 (6.9-7.18)	7.02 (6.9-7.2)	0.59
PCO2	20 (15-23)	19 (16-22)	0.71
HCO3 (mmol/L)	7.2 (5.6-10.1)	7 (5.5-9.5)	0.81
Lactate (mmol/L)	2 (1-3)	2 (1-3)	0.93
Anion gap (mmol/L)	16 (14-20)	17 (14-19)	0.77
Serum osmolality (mmol/kg)	296 (291-310)	298 (293-310)	0.56
Sodium (corrected) (meq/L)	136 (132-139)	138 (134-141)	0.84
Potassium (meq/L)	3.9 (3.4-4.2)	3.7 (3.4-4.1)	0.51
Phosphate (mg/dL)	3.4 (3.1-4)	3.8 (3.2-4)	0.48
Chloride (meq/L)	108 (104-112)	106 (101-110)	0.59
Renal function test
Urea (mg/dL)	35 (28-61)	32 (25-54)	0.23
Creatinine (mg/dL)	0.7 (0.4-1.2)	0.7 (0.5-1.3)	0.65

BES: Balanced electrolyte solution; NS: Normal saline: BMI: Body mass index; DKA: Diabetic ketoacidosis; GCS: Glasgow coma scale; PCO₂: Partial pressure of carbon dioxide; HCO₃: Bicarbonate.

Table 2 Treatment details of both the groups, n (%)/median (25^th-75^th percentiles)

Characteristics	BES (n = 30)	NS (n = 30)	P value
Estimated fluid deficit (%)	7.5 (6.5-8.5)	7.5 (6.5-8.5)	0.91
Total fluid administered (L)	1.12 (0.9-1.79)	1.38 (1-1.81)	0.29
Study fluid administered (L)	0.4 (0.3-0.62)	0.44 (0.3-0.58)	0.36
Duration of study fluid (hour)	5 (3-6)	5 (3, 6)	0.77
Need of insulin hike	9 (30)	7 (23.3)	0.39
Insulin dose (maximum), unit/kg	0.05 (0.05-0.05)	0.05 (0.05-1)	0.21
Urine output (mL/kg/hour) till end-point	2.6 (2-4)	2.5 (2-4)	0.63
Total fluid balance (mL/kg)	34 (14-52)	36 (16-55)	0.54

BES: Balanced electrolyte solution.

Table 3 Outcomes (primary and secondary) in both the groups, n (%)/median (25^th-75^th percentiles)

Characteristics	BES (n = 30)	NS (n = 30)	P value
Primary outcome
Time taken for resolution of acidosis (hour)	12 (8-18)	16 (10-22)	0.16
Secondary outcomes
Duration of hospital stay (day)	4 (3-5)	5 (3-6)	0.23
Complications
Acute kidney injury1	0 (0)	3 (10)	0.07
Cerebral edema	0 (0)	1 (3.3)	0.21
Required mechanical ventilation	1 (3.3)	1 (3.3)	0.86
Required inotropes	1 (3.3)	0 (0)	0.21
Hypernatremia	1 (3.3)	1 (3.3)	0.86
Hyponatremia	5 (16.7)	4 (13.3)	0.42
Hyperchloremia	1 (3.3)	3 (10)	0.09
Hypokalemia	3 (10)	5 (16.7)	0.08

¹New onset or progressive.

BES: Balanced electrolyte solution; NS: Normal saline.