Time to Resolution of Diabetic Ketoacidosis by Ringers Lactate Solution Versus Normal Saline An open labelled Randomised Controlled Trial

The prevalence of diabetes in worldwide is estimated to be 10.5% of adults aged 20-79 years (around 537million) in 2021.This is expected to rise to 643million in 2030 and 783 million in 2045.

DKA is a life-threatening complication of diabetes that can occur in both individuals affected by TYPE I AND TYPE II DM. It is a condition of absolute or near absolute insulin deficiency characterized by hyperglycaemia, ketone body formation and acidosis. Prevalence of DKA in diabetics varies depending on the type of diabetes, patient’s age, insulin type, race, ethnicity, etc.

Incidence of DKA in type 1 DM is roughly estimated to be around 1 out of 2000. (About 3% of patients of T1DM initially present as DKA) .There is also an increase of incidence of DKA in type 2DM (Ketosis prone type 2DM, also known as Flatbush diabetes)

For the management of DKA, it is necessary to replenish the fluid deficit, correct the electrolyte imbalance, insulin therapy along with treatment of the precipitating factors

Fluid replacement therapy should be the first and most important therapeutic measure in DKA even before  initiaton of insulin. Typical fluid loss in DKA is estimated to be around  100ml/kg which is about 7L in a 70 kg individual.

Current guidelines recommend 0.9% Sodium chloride as the replacement fluid of choice and is widely preferred because of its effective restoration of fluid deficit and easy availability, however because of its higher chloride content, it is also associated with hyperchloremia causing NAGMA (normal anion gap metabolic acidosis), thus prolonging the time taken to resolution of DKA, thereby leading to prolonged hospital stay. After the initial resuscitation, in patients with normal or high sodium levels, fluids are switched to 0.45% NaCl.

Various studies have demonstrated the faster resolution of acidosis with balanced crystalloid solutions as compared to 0.9% saline.

Previous studies have shown the use of Sterofundin being associated with earlier resolution of DKA, lesser IV fluid requirement, lesser IV insulin requirement, and less requirement of 0.45%NS with shorter hospital stay. Although NS is more commonly used because of its easy availability, it carries a higher risk of hyperchloremic metabolic acidosis which further prolongs the resolution of acidosis

Currently the controversy revolves around selecting either Normal Saline or Balanced Electrolyte Solution (such as Lactated  Ringer’s solution, Sterofundin or PlasmaLyte)

Electrolyte contents of RL closely resemble those of plasma, hence can be rapidly infused without risk of causing any electrolyte imbalances. Lactate in RL is metabolised and converted to bicarbonate by liver which makes it valuable for treatment of metabolic acidosis.

Our study aims at comparing the difference in outcome on using 0.9% saline  and ringer’s lactate by using primary and secondary objectives