Comparing Sterofundin to 0.9% Sodium Chloride Infusion in Managing Diabetic Ketoacidosis: A Pilot Study

Abstract

ABSTRAK Penggantian cecair adalah rawatan utama untuk kencing manis ketoacidosis (DKA). Pada masa ini pilihan terbaik daripada cecair masih diperdebatkan. 0.9% Normal Saline (NS) yang menyebabkan ketidakseimbangan metabolik dan asidosis metabolik biasanya digunakan. Sterofundin® merupakan kristaloid & Health Dec 2017;12(2): 179-192 Rossman H. et al. (Malaysian Clinical Practice Guidelines 2015). The ideal fluid for managing diabetic ketoacidosis (DKA) is controversial. Following substantial fluid loss due to osmotic diuresis, fluid deficit can be estimated up to 100 ml/ kg which is corrected within 24 hrs. Crystalloid 0.9% normal saline (NS) is currently the mainstay therapy for fluid replacement. Fluid replacement regiment for a systolic BP > 90 mmHg is 1000 mL of NS for the 1 st hr, another 1000 mL of NS for next 2 hrs and 1000 Kata kunci: jurang anion, diabetic ketoacidoses, keton, ph , saline, sterofundin ABSTRACTFluid replacement is the mainstay treatment for diabetic ketoacidosis (DKA). Currently, the best choice of fluids is still debatable. An amount of 0.9% sodium chloride is commonly used. Sterofundin® is an alternative crystalloid that is assumed to expedite resolution of acidosis. Advantages in sterofundin content being smaller significant ion difference (SID) to plasma and lower chloride content. The main objective of the study was to compare rate of acidosis resolution in DKA patients between treatment with 0.9% normal saline and Sterofundin over 12 hrs. Other objectives were to compare significant ion difference (SID), 12-hr blood ketone clearance and electrolyte balance between the two groups. The study was a prospective open labelled randomized control trial. This study was conducted over 6 months. Sample size of 18 was obtained with 9 for each arm. Main difference between two groups was initial median 2-hr pH level improvement (NS = +0.006 vs. Sterofundin = +0.05, P=0.063), however not being significant. Ketone, anion gap reduction, bicarbonate normalisation, sodium, chloride, urea and creatinine levels failed to show any significant differences between both groups. Twelve-hour median chloride levels increments were higher in the NS group (+11) compared to the sterofundin group (+6). There was no difference between mortality and morbidity. Comparing the two fluid groups, there was no significant biochemical differences during treatment of DKA. This was a pilot study that can initiate further clinical trials.

Fluid resuscitation with balanced electrolyte solutions results in faster resolution of diabetic ketoacidosis than with 0.9% saline in adults – A systematic review and meta‐analysis

“…50 In the study conducted by Rossman et al, the length of follow-up was only 12 h due to logistic considerations and financial constraints, consequently there was not enough time for complete resolution of acidosis and ketone clearance. 48 Furthermore, inclusion and exclusion criteria in the evaluated articles differed, for example, Comorbidity Index Scores did not show any differences between the BES and 0.9% Saline-groups in these studies.…”

“…For this reason, we publish the forest plot of this outcome only in the Supplementary material (Additional File .) 3,47–50 …”

“…3,28 After duplicate removal, 5345 studies were left for the title and abstract selection; in the next step, 37 studies were found potentially useful for full-text selection, and 29 of them were assessed for eligibility; ultimately, ten records were considered for data extraction in our meta-analysis. 3,28,[43][44][45][46][47][48][49][50] Our study selection and screening process, along with our reasons for exclusion, are depicted in the PRISMA flow diagram (Figure 1).…”

“…Sardar et al included subjects aged between 20 and 60 years, while Rossman et al set no upper age limit. 28,48 Another important limitation is that the treatment protocol for DKA varies from country to country, and the protocol itself was not always fixed in the studies, which may have led to differences, for example, some hospitals used bicarbonate to resolve DKA, while others limited its use. [6][7][8][9] The volume of fluid administered during resuscitation in DKA could also have a substantial impact on the outcomes.…”

Comparing the clinical effects of balanced electrolyte solutions versus normal saline in managing diabetic ketoacidosis

“…We excluded six trials because five of them were observational studies,[ 14 15 16 17 18 ] and the remaining was a systematic review protocol. [ 19 ] Following the completion of the qualitative synthesis, one study[ 20 ] was excluded due to a lack of outcome interest. Therefore, eight trials involving 595 participants were embraced in the meta-analysis and systematic review [ Figure 1 and Table 1 ].…”